FDA Adverse Event Injury Summary report: N

PS

MDR report key: 3030632 · Received April 2, 2013

Report

Report Number
1020279-2013-00192
Event Type
Injury
Date Received
April 2, 2013
Date of Event
March 13, 2013
Report Date
March 29, 2013
Manufacturer
SMITH & NEPHEW, INC.
Product Code
JWH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
JA
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT A REVISION WAS PERFORMED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
134275 PS GII PS HI FLEX ISRT SZ 5-6 9 JWH SMITH & NEPHEW, INC.

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention