FDA Adverse Event
Injury
Summary report: N
CONSERVE(R) PLUS CUP
MDR report key: 2110655
·
Received June 1, 2011
Report
- Report Number
- 1043534-2011-00245
- Event Type
- Injury
- Date Received
- June 1, 2011
- Date of Event
- April 26, 2011
- Report Date
- April 28, 2011
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWA
- PMA / PMN Number
- K021349
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN.COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND FOR (B)(4) LOT NO: 079885346. DEVICE HISTORY RECORD REVIEWED. PACKAGE INSERT REVIEWED. PRODUCT NOT RETURNED.(B)(4).
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00246.
Description of Event or Problem · 1
ALLEGEDLY REVISED DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSERVE(R) PLUS CUP | HIP COMPONENT | KWA | WRIGHT MEDICAL TECHNOLOGY, INC. | 079885346 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization| R |