MAUDE Adverse Event Report: ZIMMER, INC.; DERMATOME

Catalog Number 8801-01

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

Patient Problem Tissue Damage (2104)

Event Date 09/19/2019

Event Type  malfunction  

Event Description

The patient was undergoing a split skin graft and the dermatome cut too deeply through the skin.Doctor closed the wound with a few sutures.The dermatome was sequestered.

• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER, INC.; 1800 w. center street; warsaw IN 46580
• MDR Report Key: 9224353
• MDR Text Key: 163323795
• Report Number: 9224353
• Device Sequence Number: 1
• Product Code: GFD
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8801-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14600 DA