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2026 data FDA MAUDE openFDA

Tissue Expander And Accessories

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

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Tissue Expander And Accessories LIGHT-BOOK · MAUDE

#313 of 1000 · 4,977 reports · 1993–2026

  • BOOK 4,977 reports
  • RANK #313 of 1000
  • DEATH 4 death-typed
  • INJ 4,100 injury-typed
  • MALF 769 malfunction
  • SPAN 1993–2026
  • PEAK 2020: 639
  • PHOTO Monitor

Nearest event-volume peer: Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass (9 report gap)

Tissue Expander And Accessories sits #313 of 1000 among tracked device types with 4,977 MAUDE reports spanning 1993–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 82.4% corpus 30.4% · above corpus mean (+51.9 pp)
  • MALF 15.5% corpus 64.5% · below corpus mean (-49.1 pp)

Lead product-problem code Material Rupture is 39% of coded problems · Lead manufacturer MENTOR TEXAS accounts for 55% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Tissue Expander And Accessories in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Tissue Expander And Accessories carries 4,977 MAUDE reports, ranked #313 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 4,100 (82.4%)
Malfunction 769 (15.5%)
Other 53 (1.1%)
51 (1.0%)
Death 4 (0.1%)

Patient Outcomes

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

Required Intervention 3,594 (68.8%)
Other 625 (12.0%)
569 (10.9%)
Hospitalization 146 (2.8%)
R 141 (2.7%)
O 42 (0.8%)
S 35 (0.7%)
Disability 21 (0.4%)
L 16 (0.3%)
Life Threatening 16 (0.3%)
H 13 (0.2%)
Death 4 (0.1%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Material Rupture 1,733
Adverse Event Without Identified Device or Use Problem 930
Fluid/Blood Leak 733
Break 139
Device Appears to Trigger Rejection 131
Off-Label Use 105
No Apparent Adverse Event 90
Patient-Device Incompatibility 84
Improper or Incorrect Procedure or Method 63
Deflation Problem 54
Migration 47
Device Contamination with Chemical or Other Material 45
Use of Device Problem 44
Appropriate Term/Code Not Available 41
Defective Device 40
Device Handling Problem 33
Connection Problem 31
Insufficient Information 28
Device Contaminated During Manufacture or Shipping 26
Inflation Problem 26

Yearly Trend

93
1993: 7
94
1994: 31
95
1995: 37
96
1996: 52
97
1997: 89
98
1998: 57
99
1999: 34
00
2000: 17
01
2001: 19
02
2002: 19
03
2003: 21
04
2004: 13
05
2005: 10
06
2006: 13
07
2007: 10
08
2008: 24
09
2009: 21
10
2010: 58
11
2011: 16
12
2012: 31
13
2013: 47
14
2014: 20
15
2015: 13
16
2016: 38
17
2017: 111
18
2018: 518
19
2019: 554
20
2020: 639
21
2021: 440
22
2022: 499
23
2023: 473
24
2024: 488
25
2025: 500
26
2026: 58

Related Entities for Tissue Expander And Accessories

Top Manufacturers

MENTOR TEXAS 2,241
ALLERGAN (COSTA RICA) 1,698
ALLERGAN 70
SIENTRA, INC 43

Event Locations

2,404 (48.3%)
I 2,069 (41.6%)
HOSPITAL 275 (5.5%)
NO INFORMATION 72 (1.4%)
INVALID DATA 49 (1.0%)
UNKNOWN 42 (0.8%)
HOME 34 (0.7%)
OTHER 12 (0.2%)
AMBULATORY SURGICAL FACILITY 11 (0.2%)
NOT APPLICABLE 6 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare MENTOR TEXAS vs ALLERGAN (COSTA RICA) →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Tissue Expander And Accessories, 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 (4,977 here).

Monitor 4,968 Prosthesis 5,047 Prosthesis 5,047 Expander, Surgical, Skin Graft 5,056

Similar death-typed counts

Nearest other device types by death-typed report count (4 here), distinct from the volume row.

Catheter, Urethral 4 Disinfectant, Medical Devices 4 Drill, Surgical, Ent Including Handpiece 4 Electrode 4

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

Disclaimer: MAUDE figures for Tissue Expander And Accessories 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 Tissue Expander And Accessories; 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.