FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PHYSIO II RING
MDR report key: 1821175
·
Received August 31, 2010
Report
- Report Number
- 2015691-2010-13969
- Event Type
- Injury
- Date Received
- August 31, 2010
- Date of Event
- July 22, 2010
- Report Date
- August 2, 2010
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K083470
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS WAS CONSIDERED FOR REPORT ONLY. CUSTOMER LETTER NOT REQUESTED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. NO CUSTOMER LETTER REQUIRED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. NO PRODUCT RETURN. DEVICE WAS DISCARDED BY HOSPITAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND A VALVE (B)(4) WAS IMPLANTED AS A REPLACEMENT FOR UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED. INFORMATION WAS LEARNED THROUGH (B)(4) IMPLANT PATIENT REGISTRY. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PHYSIO II RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 5200 | R-10B0269 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Hospitalization| R |