FDA Adverse Event
Injury
Summary report: N
IM NAIL
MDR report key: 3120130
·
Received May 20, 2013
Report
- Report Number
- 1020279-2013-00268
- Event Type
- Injury
- Date Received
- May 20, 2013
- Date of Event
- January 29, 2013
- Report Date
- January 29, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS ORIGINALLY REPORTED THAT A REVISION SURGERY WAS PERFORMED, BUT FURTHER INFORMATION INDICATED THE SURGEON DID NOT FAULT THE SMITH & NEPHEW NAIL ON THE ORIGINAL SURGERY. REPORT 1020279-2013-00268 FILED IN ERROR.
Description of Event or Problem · 1
IT WAS ORIGINALLY REPORTED THAT A REVISION SURGERY WAS PERFORMED, BUT FURTHER INFORMATION INDICATED THE SURGEON DID NOT FAULT THE SMITH & NEPHEW NAIL ON THE ORIGINAL SURGERY. REPORT 1020279-2013-00268 FILED IN ERROR.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221779 | IM NAIL | IMPLANT | JDS | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |