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

Model Number	3539252
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: DERMATOME
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 311 enterprise dr; plainsboro NJ 08536
• MDR Report Key: 8980318
• Report Number: 8980318
• Device Sequence Number: 3330217
• Product Code: GFD
• UDI-Device Identifier: 10381780277965
• UDI-Public: (01)10381780277965
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/20/2019
• Report Date (Section F): 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3539252
• Device Catalogue Number: 3539252
• Device Lot Number: W1805011
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 83
• Date Report Sent to FDA: 08/20/2019