MAUDE Adverse Event Report: ZIMMER, INC. AIR DERMATOME HAND PIECE

Model Number 8801001

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

Patient Problems Pain (1994); Scarring (2061)

Event Date 04/15/2019

Event Type  Injury  

Event Description

Air dermatome machine malfunctioned resulting in pt scarring and excessive pain.Fda safety report id# (b)(4).

• Brand Name: AIR DERMATOME HAND PIECE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER, INC. ; warsaw IN
• MDR Report Key: 8531595
• MDR Text Key: 142636629
• Report Number: MW5085999
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• 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: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8801001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Hospitalization
• Patient Age: 49 YR
• Patient Weight: 91