MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-04-16 for RLV 4103202 * manufactured by Quest Medical, Inc..
[16786026]
At an amsect meeting, the customer reported leaking with the valve. The amount and location is unknown. The customer receives the valve in a pack. The customer stated it is from an older lot-they do not rotate their packs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2003-00023 |
| MDR Report Key | 454928 |
| Report Source | 05,06 |
| Date Received | 2003-04-16 |
| Date of Report | 2003-04-16 |
| Date of Event | 2003-03-08 |
| Date Mfgr Received | 2003-03-08 |
| Date Added to Maude | 2003-04-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KATHRYN THOMPSON |
| 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 | RLV |
| Generic Name | VACCUM RELIEF VALVE |
| Product Code | MNJ |
| Date Received | 2003-04-16 |
| Model Number | 4103202 |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 443925 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY. ALLEN TX 75002 US |
| Baseline Brand Name | RLV KT9116105 |
| Baseline Generic Name | VACCUM RELIRT VALVE |
| Baseline Model No | 4103202 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-04-16 |