FDA Adverse Event
Injury
Summary report: N
UNK DEPUY PRODUCT
MDR report key: 1002211
·
Received February 21, 2008
Report
- Report Number
- 1818910-2008-00302
- Event Type
- Injury
- Date Received
- February 21, 2008
- Report Date
- January 25, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- HWC
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
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
DEPUY ORTHOPAEDICS RECEIVED A SUMMONS REGARDING A LAWSUIT THAT HAS BEEN FILED IN THE COURT OF COMMON PLEAS. THE REASON FOR THE LAWSUIT AND THE PRODUCT INVOLVED ARE NOT KNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK DEPUY PRODUCT | PRODUCT UNK | HWC | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |