MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-11-29 for URINE DRAINAGE BAG 3T5904 manufactured by Plasco, Inc..
[20088]
Per healthcare professional, bags are not draining and urine is backing up into tubing. No customer injury or complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1483039-1995-00026 |
| MDR Report Key | 28864 |
| Date Received | 1995-11-29 |
| Date of Report | 1995-11-27 |
| Date Facility Aware | 1995-11-20 |
| Report Date | 1995-11-27 |
| Date Reported to FDA | 1995-11-28 |
| Date Reported to Mfgr | 1995-11-20 |
| Date Added to Maude | 1995-12-20 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URINE DRAINAGE BAG |
| Generic Name | URINE DRAINAGE BAG |
| Product Code | EYZ |
| Date Received | 1995-11-29 |
| Catalog Number | 3T5904 |
| Lot Number | 6852-415 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29840 |
| Manufacturer | PLASCO, INC. |
| Manufacturer Address | 3849 SWANSON CT GURNEE IL 60031 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-11-29 |