FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
MDR report key: 1081702
·
Received July 22, 2008
Report
- Report Number
- 6000002-2008-08139
- Event Type
- Death
- Date Received
- July 22, 2008
- Date of Event
- November 16, 2007
- Report Date
- November 16, 2007
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K926138
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO UNKNOWN REASONS. DATE OF DEATH IS UNKNOWN. AWARE DATE IS USED AS INCIDENT DATE. IT WAS ADDITIONALLY REPORTED THAT THREE OTHER DEVICES WERE IMPLANTED. PLEASE REFER TO MFR #6000002-2008-05548 (MODEL #2800), MFR #6000002-2008-08136 (MODEL #3000TFX), AND MFR #6000002-2008-08138 (MODEL #4600).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4450M28 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |