FDA Adverse Event
Other
Summary report: N
NONE
MDR report key: 1053024
·
Received May 27, 2008
Report
- Report Number
- 1644408-2008-00164
- Event Type
- Other
- Date Received
- May 27, 2008
- Report Date
- April 23, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO INFO FOR THIS COMPLAINT RECEIVED. ENCORE HAS CONTACTED THE INITIAL REPORTER FOR THE REQUIRED INFO. WHEN THE INFO IS RECEIVED, ENCORE WILL FILE A FOLLOW-UP REPORT.
Description of Event or Problem · 1
ENCORE NOTIFIED OF A REVISION SURGERY. NO OTHER INFO HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | JDI | ENCORE MEDICAL, L.P. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |