MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. SKIN-TRAC; APPARATUS, TRACTION, NON-POWERED

Catalog Number 3874-03

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 05/15/2020

Event Type  malfunction  

Event Description

Tape stuck to the patient.

• Brand Name: SKIN-TRAC
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 56 east bell drive; warsaw IN 46581
• MDR Report Key: 10655649
• MDR Text Key: 210675392
• Report Number: 10655649
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3874-03
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1