FDA Adverse Event
Injury
Summary report: N
R3
MDR report key: 1833650
·
Received September 14, 2010
Report
- Report Number
- 1020279-2010-00263
- Event Type
- Injury
- Date Received
- September 14, 2010
- Date of Event
- August 10, 2010
- Report Date
- September 14, 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 EXTENDED TO DUE THE TROUBLE INSERTING THE DEVICE. ANOTHER DEVICE WAS USED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | R3 | LINER | JDH | SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE | 07HM18570 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |