FDA Adverse Event Injury Summary report: N

R3

MDR report key: 1832766 · Received September 13, 2010

Report

Report Number
1020279-2010-00260
Event Type
Injury
Date Received
September 13, 2010
Date of Event
July 27, 2010
Report Date
August 13, 2010
Manufacturer
SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE
Product Code
JDH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT SURGERY WAS DELAYED DUE TO NOT BEING ABLE TO IMPLANT THE DEVICE. ANOTHER PART WAS USES SUCCESSFULLY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 R3 LINER JDH SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE 07FM23386

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization