FDA Adverse Event
Injury
Summary report: N
TROCH ENTRY LH 12MMX34CM
MDR report key: 1772341
·
Received July 23, 2010
Report
- Report Number
- 1818910-2010-04783
- Event Type
- Injury
- Date Received
- July 23, 2010
- Report Date
- June 23, 2010
- Manufacturer
- DEPUY ACE S.A. 'R.L.
- Product Code
- HSB
- PMA / PMN Number
- K033329
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE PT WAS REVISED DUE TO PAIN AND BROKEN NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TROCH ENTRY LH 12MMX34CM | 87HSB | HSB | DEPUY ACE S.A. 'R.L. | NA | DGGCVJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |