MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-09-22 for AEROSOL DRAINAGE BAG, "Y" ADAPTOR 974Y-E manufactured by Unomedical Inc..
[15031550]
When using item 974y-e on a pt, the bag came loose from the wye attachment. Pt was fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680866-2005-00003 |
| MDR Report Key | 654294 |
| Report Source | 05 |
| Date Received | 2005-09-22 |
| Date of Report | 2005-09-20 |
| Date of Event | 2005-08-25 |
| Date Mfgr Received | 2005-08-25 |
| Device Manufacturer Date | 2003-11-01 |
| Date Added to Maude | 2005-12-21 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | EFRAIN CARRERO - OFFICIAL CORRES |
| Manufacturer Street | 6001 SOUTH 35TH STREET, STE B |
| Manufacturer City | MCALLEN TX 78503 |
| Manufacturer Country | US |
| Manufacturer Postal | 78503 |
| Manufacturer Phone | 9566838472 |
| Manufacturer G1 | UNOMEDICAL S.A DE C.V. |
| Manufacturer Street | PARQUE INDUSTRIAL DEL NORTE SECCION 4, LOTE NO. 7 |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AEROSOL DRAINAGE BAG, "Y" ADAPTOR |
| Generic Name | DRAINAGE BAG |
| Product Code | BYH |
| Date Received | 2005-09-22 |
| Model Number | 974Y-E |
| Catalog Number | 974Y-E |
| Lot Number | 03-48 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 643762 |
| Manufacturer | UNOMEDICAL INC. |
| Manufacturer Address | * MC ALLEN TX 78503 US |
| Baseline Brand Name | AEROSOL DRANAIGE BAG, Y ADAPTOR W/HANGER |
| Baseline Generic Name | DRAINAGE BAG |
| Baseline Model No | 974Y-E |
| Baseline Catalog No | 974Y-E |
| Baseline ID | NONE |
| Baseline Device Family | AEROSOL DRAINAGE BAG |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-09-22 |