MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME; SKIN GRAFT PRODUCTS

Catalog Number 3539700

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2022

Event Type  Injury  

Manufacturer Narrative

The dermatome (id r3539700) was returned for evaluation: device history record (dhr) -a review was conducted and shows no abnormalities related to the reported failure.Failure analysis/root cause - no function or calibration issues were found.However, there was evidence of damage due to mishandling, which could have caused the reported "skipping".A team from integra have a scheduled in-service at this account.This visit will address the cleaning, handling, and use issues found during our investigation.

Event Description

A facility reported a dermatome (id r3539700) was able to work, but the skin harvest was a "disaster".The first graft had a big gap in the middle.A new blade was used and the second graft skipped along the skin and there was black fluid dripping out of the dermatome into the wound.The site was in the anterior right thigh.Another device was used to complete the procedure.A delay was noted in completing the procedure (unknown for how long) and patient injury was reported.

• Brand Name: PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME
• Type of Device: SKIN GRAFT PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16000714
• MDR Text Key: 305682443
• Report Number: 3004608878-2022-00267
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3539700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2022
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1