FDA Adverse Event Summary report: N

1020279-2014-00416

MDR report key: 3932688 · Received July 14, 2014

Report

Report Number
1020279-2014-00416
Date Received
July 14, 2014
Date of Event
September 4, 2012
Report Date
August 9, 2013
Manufacturer
SMITH & NEPHEW, INC.
Product Code
JWH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED. THE REASON IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
409784 JWH SMITH & NEPHEW, INC.

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention