FDA Adverse Event
Injury
Summary report: N
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
MDR report key: 1111023
·
Received August 12, 2008
Report
- Report Number
- 6000002-2008-08397
- Event Type
- Injury
- Date Received
- August 12, 2008
- Date of Event
- June 27, 2008
- Report Date
- August 2, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K923367
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED APPROX AFTER IMPLANT DURATION OF 16 MONTHS, DUE TO UNK REASONS. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COSGROVE-EDWARDS ANNULOPLASTY SYSTEM | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4600 | R-06M0794 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |