MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA PADGETT DERMATOME - HANDPIECE ONLY INCLUDES CLIP; SKIN GRAFT PRODUCTS

Catalog Number DP0001

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

Patient Problem Laceration(s) (1946)

Event Date 10/01/2020

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 facility reported the blade of the integra padgett dermatome was able to be placed/secured on a zimmer air dermatome sink grafting system causing a laceration.No additional information was provided after several attempts.

Event Description

N/a.

Manufacturer Narrative

The padgett dermatome was not returned for evaluation (as per customer, product not available), however, customer reported using a padgett blade on a zimmer system.These are incompatible devices.Therefore, the root cause of the laceration is most likely the aforementioned improper use.The root cause of the laceration is most likely the aforementioned improper use.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.Additional information was received: the dermatome was used for a repair of a congenital aural atresia.The graft site was the thigh.The laceration was a full thickness laceration requiring stitches.Another graft site was required to complete the procedure.

• Brand Name: PADGETT DERMATOME - HANDPIECE ONLY INCLUDES CLIP
• 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: 12556290
• MDR Text Key: 274103809
• Report Number: 3004608878-2021-00578
• 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: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DP0001
• Device Lot Number: 23293
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1