MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-05 for VRV-II VACUUM RELIEF VALVE 4004203 manufactured by Quest Medical, Inc.
| Report Number | 1649914-2019-00029 |
| MDR Report Key | 8672720 |
| Date Received | 2019-06-05 |
| Date of Report | 2019-07-18 |
| Date Mfgr Received | 2019-05-13 |
| Date Added to Maude | 2019-06-05 |
| 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 | 3 |
| Manufacturer Contact | TOSAN ONOSODE |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Manufacturer G1 | QUEST MEDICAL, INC. |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VRV-II VACUUM RELIEF VALVE |
| Generic Name | CPBP SUCTION CONTROL DEVICE |
| Product Code | DWD |
| Date Received | 2019-06-05 |
| Returned To Mfg | 2019-06-18 |
| Model Number | 4004203 |
| Lot Number | 054814 AND 054758 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-06-05 |