MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT; SKIN GRAFT PRODUCTS

Catalog Number	3539250
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The model b110 v electro dermatome complete kit (3539250) was not returned for evaluation; therefore, an evaluation of the device could not be performed.The root cause(s) of the reported issue could not be determined.However, based on the information provided about the alleged incident, it is possible that heavy wear over time played a role, and/or use error (for example, attaching the width clips too tight).If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT
• Common Device Name: SKIN GRAFT PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22020900
• Report Number: 3004608878-2025-00099
• Device Sequence Number: 21208410
• Product Code: GFD
• UDI-Device Identifier: 10381780282365
• UDI-Public: 10381780282365
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3539250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown