FDA Adverse Event
Other
Summary report: N
UNK
MDR report key: 1033194
·
Received April 21, 2008
Report
- Report Number
- 1644408-2008-00141
- Event Type
- Other
- Date Received
- April 21, 2008
- Date of Event
- March 24, 2008
- Report Date
- April 21, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- HSH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ENCORE IS IN THE PROCESS OF COLLECTING ALL REQUIRED INFO. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INFO IS RECEIVED.
Description of Event or Problem · 1
REVISION SURGERY - RECEIVED NOTIFICATION OF A REVISION SURGERY AT A MEDICAL CENTER IN 2008. NO FURTHER INFO HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | UNK | HSH | ENCORE MEDICAL, L.P. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |