FDA Adverse Event
Injury
Summary report: N
CONSERV PLUS SPIKED CUP
MDR report key: 1060245
·
Received June 11, 2008
Report
- Report Number
- 1043534-2008-00129
- Event Type
- Injury
- Date Received
- June 11, 2008
- Date of Event
- April 15, 2008
- Report Date
- April 22, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWA
- PMA / PMN Number
- K031963
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY. EVENT DEVICE CODE IS ADDRESSED IN PACKAGE INSERT. PRODUCT NOT RETURNED FOR EVALUATION. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2008-00160.
Description of Event or Problem · 1
ACTIVE, PLAYS TENNIS. ALLEGEDLY REVISED DUE TO SUPERFICIAL INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSERV PLUS SPIKED CUP | KWA | WRIGHT MEDICAL TECHNOLOGY, INC. | 096370928 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |