MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION "PADGETT" INSTRUMENTS/DERMATOME AIR

Model Number AIR MODEL C, SN0336

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

Patient Problem Laceration(s) (1946)

Event Date 11/13/2020

Event Type  Injury  

Event Description

Deep laceration sustained during skin graft "harvest" requiring repair of injured muscles.

• Brand Name: "PADGETT" INSTRUMENTS/DERMATOME AIR
• Type of Device: DERMATOME
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 11108109
• MDR Text Key: 225148310
• Report Number: MW5098630
• Device Sequence Number: 1
• Product Code: GFD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AIR MODEL C, SN0336
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 61