Integra® Padgett® Dermatomes 3539250Recalls & reported problems
Integra Lifesciences Corporation · Model B (120V) - Dermatome Complete Kit - USA/Canada Only · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780282365), received between May 14, 2025 and May 14, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Calibration Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Calibration Problem1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2025Calibration Problem; Calibration Problem
A FACILITY REPORTED A MODEL B DERMATOME (ID 3539250) WAS USED FOR A HIP SKIN GRAFT AND IT SKIPPED CAUSING SKIN DAMAGE. THE GRAFT TAKEN WAS NO USABLE, THEREFORE, ANOTHER SKIN GRAFT WAS REQUIRED. THERE WAS GREASE EMBEDDED IN THE WOUND FROM THE DERMATOME AND MEDICAL STAFF WERE ABLE TO SCRUB THAT OUT. THE EVENT LED TO 30-45 MINUTES SURGICAL DELAY. NO SIGNS OF INFECTION.
Patient problems: Laceration(s)
MAUDE report 22020900 ↗
Other DERMATOME devices
- Dermatome 00-8801-001-00Zimmer Orthopaedic Surgical Products, Inc. · Dermatome1 recall631 reports
- Dermatome 00-8821-001-00Zimmer Orthopaedic Surgical Products, Inc. · Dermatome614 reports
- Dermatome 88710100Zimmer Orthopaedic Surgical Products, Inc. · DERMATOME242 reports
- Dermatome 00-8800-000-10Zimmer Orthopaedic Surgical Products, Inc. · Dermatome1 recall109 reports
- NA 00-8851-002-06Zimmer Orthopaedic Surgical Products, Inc. · DERMATOME22 reports
- ACCULAN 3TI GA670Aesculap AG · Dermatome6 reports
- Air Dermatome 00-8801-002-00Zimmer Orthopaedic Surgical Products, Inc. · Dermatome5 reports
- NA 00-8851-002-05Zimmer Orthopaedic Surgical Products, Inc. · DERMATOME3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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