What are FDA adverse event reports for Sleeve, Limb, Compressible?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Sleeve, Limb, Compressible, there are 1,664 total reports including 19 death reports and 302 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Sleeve, Limb, Compressible?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Sleeve, Limb, Compressible

Name: Sleeve, Limb, Compressible - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Sleeve, Limb, Compressible LIGHT-BOOK · MAUDE

#526 of 1000 · 1,664 reports · 1992–2026

BOOK 1,664 reports
RANK #526 of 1000
DEATH 19 death-typed
INJ 302 injury-typed
MALF 1,135 malfunction
SPAN 1992–2026
PEAK 2013: 169
PHOTO Adhesive

Nearest event-volume peer: Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer (1 report gap)

Sleeve, Limb, Compressible sits #526 of 1000 among tracked device types with 1,664 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

DEATH 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
INJ 18.1% corpus 30.4% · below corpus mean (-12.3 pp)
MALF 68.2% corpus 64.5% · above corpus mean (+3.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 11% of coded problems · Lead manufacturer COVIDIEN accounts for 95% of manufacturer-tagged reports · Top event location HOSPITAL is 38% of location-tagged rows .

Ear

1,672
Marker

1,671
Apparatus

1,667
Sleeve (this)

1,664
Adhesive

1,663
Monitor

1,663

What this shows Sleeve, Limb, Compressible carries 1,664 MAUDE reports, ranked #526 of 1000.

Event Types

Malfunction 1,135 (68.2%)

Injury 302 (18.1%)

Other 158 (9.5%)

50 (3.0%)

Death 19 (1.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

1,091 (62.8%)

Other 365 (21.0%)

Required Intervention 107 (6.2%)

Hospitalization 58 (3.3%)

R 41 (2.4%)

Death 20 (1.2%)

S 14 (0.8%)

Disability 11 (0.6%)

Life Threatening 10 (0.6%)

O 8 (0.5%)

L 6 (0.3%)

H 4 (0.2%)

Invalid Data 3 (0.2%)

Yearly Trend

1992: 5

1994: 4

1995: 7

1996: 9

1997: 9

1998: 9

1999: 16

2000: 14

2001: 19

2002: 14

2003: 23

2004: 23

2005: 32

2006: 28

2007: 12

2008: 36

2009: 45

2010: 66

2011: 50

2012: 100

2013: 169

2014: 93

2015: 137

2016: 150

2017: 149

2018: 114

2019: 102

2020: 50

2021: 34

2022: 27

2023: 57

2024: 30

2025: 24

2026: 7

Top Manufacturers

COVIDIEN 631

ZIMMER SURGICAL, INC. 36

Event Locations

HOSPITAL 639 (38.4%)

I 568 (34.1%)

344 (20.7%)

OTHER 43 (2.6%)

NO INFORMATION 26 (1.6%)

UNKNOWN 15 (0.9%)

AMBULATORY SURGICAL FACILITY 9 (0.5%)

INVALID DATA 9 (0.5%)

OUTPATIENT TREATMENT FACILITY 6 (0.4%)

HOME 4 (0.2%)

NURSING HOME 1 (0.1%)

Compare COVIDIEN vs ZIMMER SURGICAL, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Sleeve, Limb, Compressible, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,664 here).

Adhesive 1,663 Monitor, Physiological, Patient 1,663 Apparatus 1,667 Marker, Radiographic, Implantable 1,671

Similar death-typed counts

Nearest other device types by death-typed report count (19 here), distinct from the volume row.

Electrode, Electrosurgical 19 Pacemaker, Cardiac, External Transcutaneous 19 Recorder, Event, Implantable Cardiac, 19 Transducer, Pressure, Catheter Tip 19

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Sleeve, Limb, Compressible are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Sleeve, Limb, Compressible; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.

Sleeve, Limb, Compressible

Event-type mix vs corpus