FDA Adverse Event
Malfunction
Summary report: N
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING
MDR report key: 1081843
·
Received July 17, 2008
Report
- Report Number
- 6000002-2008-08080
- Event Type
- Malfunction
- Date Received
- July 17, 2008
- Date of Event
- September 21, 2007
- Report Date
- October 11, 2007
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K032250
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED AND EXPLANTED IN 2007, DUE TO USING WRONG DEVICE BECAUSE OF INCOMPLETE LABELING ON THE BOX AS LEARNED FROM IMPLANT PATIENT REGISTRY. PER RESPONSE FROM HOSPITAL, THE DEVICE WAS WASTED; WRONG TYPE OF RING PULLED BY STAFF, PREPPED, AND EXPLANTED AT IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4100 | R06K0463 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |