MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-08-14 for RETROGUARD ARTERIAL SAFETY VALVE 4007200 * manufactured by Quest Medical, Inc..
[19163554]
The customer reported that during prime, their end customer found a crack running halfway down the side of the housing. The sample was saved and will be returned to quest. Product code 4007200; lot number 26074.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2006-00065 |
| MDR Report Key | 773358 |
| Report Source | 00 |
| Date Received | 2006-08-14 |
| Date of Report | 2006-08-11 |
| Date Mfgr Received | 2006-07-11 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2006-10-27 |
| 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 | RETROGUARD ARTERIAL SAFETY VALVE |
| Generic Name | FLOW CHECK VALVE |
| Product Code | MJJ |
| Date Received | 2006-08-14 |
| Returned To Mfg | 2006-07-17 |
| Model Number | 4007200 |
| Catalog Number | * |
| Lot Number | 26074 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 761147 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY. ALLEN TX 75002 US |
| Baseline Brand Name | RETROGUARD |
| Baseline Generic Name | FLOW CHECK VALVE |
| Baseline Model No | 4007200 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-14 |