MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-09-19 for VACUUM RELIEF VALVE IIC--CLEAR 4004103 * manufactured by Quest Medical, Inc..
[15004779]
The customer reported that while attempting a proximal graph and using a mini sucker in the aorta, the surgeon noticed no flow at the valve. The valve was cut out and replaced. The sample was saved and will be returned to co for further eval. Product code 4004103; lot number is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2006-00098 |
| MDR Report Key | 879968 |
| Report Source | 05,06 |
| Date Received | 2006-09-19 |
| Date of Report | 2006-09-15 |
| Date of Event | 2006-09-05 |
| Date Mfgr Received | 2006-09-06 |
| Date Added to Maude | 2007-07-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MEGAN SIMS |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723909800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VACUUM RELIEF VALVE IIC--CLEAR |
| Generic Name | VACUUM RELIEF VALVE |
| Product Code | MNJ |
| Date Received | 2006-09-19 |
| Returned To Mfg | 2006-09-11 |
| Model Number | 4004103 |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 859030 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY. ALLEN TX 75002 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-19 |