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 |