MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MODEL C AIR DERMATOME COMPLETE KIT; SKIN GRAFT PRODUCTS

Catalog Number 3539500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 11/13/2020

Event Type  Injury  

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 Description

A customer reported the dermatome caused a deep laceration during skin graft "harvest" requiring repair of injured muscles.No additional information was provided after several attempts.

Manufacturer Narrative

The dermatome was not returned for evaluation (as per reporter, product not available) ; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.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.Additional information received: product id - air model c (base).Serial number - (b)(6).Incident date - (b)(6) 2020.Skin or graft site - harvest split thickness skin graft r thigh.Was another graft site required? yes.Extension of the injury - deep laceration required extensive repair.

Event Description

N/a.

• Brand Name: MODEL C AIR DERMATOME COMPLETE KIT
• Type of Device: SKIN GRAFT PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• MDR Report Key: 11408435
• MDR Text Key: 234641796
• Report Number: 3004608878-2021-00142
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3539500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1