2026 data FDA MAUDE openFDA FDA Class II

Surgical Film

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §878.3300 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Surgical Film LIGHT-BOOK · MAUDE

#623 of 1000 · 1,213 reports · 2012–2026

  • BOOK 1,213 reports
  • RANK #623 of 1000
  • DEATH 7 death-typed
  • INJ 1,143 injury-typed
  • MALF 62 malfunction
  • SPAN 2012–2026
  • PEAK 2022: 430
  • PHOTO Lithotriptor

Nearest event-volume peer: Lithotriptor, Ultrasonic (0 report gap)

Surgical Film sits #623 of 1000 among tracked device types with 1,213 MAUDE reports spanning 2012–2026. 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 →

Injury-coded reports run above the device-type norm

Surgical Film carries 94.2% INJURY-coded reports, 63.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 94.2% corpus 30.3% · above corpus mean (+63.9 pp)
  • MALF 5.1% corpus 64.8% · below corpus mean (-59.7 pp)

Lead product-problem code Patient-Device Incompatibility is 34% of coded problems · Lead manufacturer DAVOL INC., SUB. C.R. BARD, INC. accounts for 68% of manufacturer-tagged reports · Top event location is 82% of location-tagged rows .

Surgical Film in the event-volume neighbourhood

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

reports

What this shows Surgical Film carries 1,213 MAUDE reports, ranked #623 of 1000.

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

Event Types

Injury 1,143 (94.2%)
Malfunction 62 (5.1%)
Death 7 (0.6%)
1 (0.1%)

Patient Outcomes

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

Required Intervention 841 (65.3%)
Disability 153 (11.9%)
Other 145 (11.3%)
R 53 (4.1%)
Hospitalization 37 (2.9%)
S 15 (1.2%)
H 11 (0.9%)
Life Threatening 10 (0.8%)
6 (0.5%)
L 6 (0.5%)
O 5 (0.4%)
D 3 (0.2%)
Death 3 (0.2%)

Top Product Problems

Patient-Device Incompatibility 575
Defective Device 424
Patient Device Interaction Problem 395
Insufficient Device Problem Information 129
Adverse Event Without Identified Device or Use Problem 40
Device Appears to Trigger Rejection 25
Migration 22
Material Deformation 14
Incorrect, Inadequate or Imprecise Result or Readings 8
Migration or Expulsion of Device 8
No Apparent Adverse Event 8
Material Split, Cut or Torn 6
Device Contamination with Chemical or Other Material 5
Delivered as Unsterile Product 4
Tear, Rip or Hole in Device Packaging 4
Use of Device Problem 4
Device Contamination With Biological Material 3
Improper or Incorrect Procedure or Method 3
Microbial Contamination of Device 3
Expiration Date Error 2

Yearly Trend

12
2012: 1
13
2013: 1
14
2014: 2
15
2015: 4
16
2016: 9
17
2017: 33
18
2018: 23
19
2019: 17
20
2020: 71
21
2021: 98
22
2022: 430
23
2023: 125
24
2024: 196
25
2025: 111
26
2026: 92

Reports in 2025 (111) held close to the prior two-year average of 161.

Related Entities for Surgical Film

Event Locations

990 (81.6%)
I 201 (16.6%)
HOSPITAL 15 (1.2%)
OTHER 3 (0.2%)
NO INFORMATION 2 (0.2%)
HOME 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare DAVOL INC., SUB. C.R. BARD, INC. vs DAVOL INC., SUB. C.R. BARD, INC. -1213643 →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Surgical Film: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,213 here).

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Disclaimer: MAUDE figures for Surgical Film 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 Surgical Film; 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.