FDA Adverse Event
Malfunction
Summary report: N
ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE
MDR report key: 4176964
·
Received October 14, 2014
Report
- Report Number
- 1649833-2014-00011
- Event Type
- Malfunction
- Date Received
- October 14, 2014
- Date of Event
- September 2, 2014
- Report Date
- October 10, 2014
- Manufacturer
- ON-X LIFE TECHNOLOGIES, INC.
- Product Code
- LWQ
- PMA / PMN Number
- P000037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED. CURRENTLY TRYING TO GET IT BACK FOR INVESTIGATION. IF RELEVANT FURTHER INFO BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE FILED.
Description of Event or Problem · 1
HOSPITAL STATES "DEFECTIVE VALVE". NO OTHER INFO HAS BEE PROVIDED,SO NO INVESTIGATION IS POSSIBLE UNTIL AND UNLESS VALVE IS RETURNED TO ONXLTI. INTRA-OPERATIVE, NO KNOWN EFFECT ON PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650687 | ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE | MECHANICAL HEART VALVE | LWQ | ON-X LIFE TECHNOLOGIES, INC. | ONXACE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |