MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION INTEGRA® PADGETT® DERMATOMES

Model Number 3539252

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2019

Event Type  malfunction  

Event Description

While performing a skin graft, the dermatome was noted to have a divot in the blade which caused the patient's graft to have to be repeated.

• Brand Name: INTEGRA® PADGETT® DERMATOMES
• Type of Device: DERMATOME
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 311 enterprise dr; plainsboro NJ 08536
• MDR Report Key: 8980318
• MDR Text Key: 157098980
• Report Number: 8980318
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 10381780277965
• UDI-Public: (01)10381780277965
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3539252
• Device Catalogue Number: 3539252
• Device Lot Number: W1805011
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15330 DA
• Patient Weight: 83