MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-04 for N/A 3T5904 manufactured by Plasco.
[9706]
Pt taken to er where 2000 ml of urine was drained from her bladder. The bags seem to plug up after being used for a short time. Urine begins to drain into the bag, but much more urine is retained in the bladder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1483039-1994-00002 |
| MDR Report Key | 11882 |
| Date Received | 1994-03-04 |
| Date of Report | 1994-02-10 |
| Date Facility Aware | 1994-02-01 |
| Report Date | 1994-02-04 |
| Date Reported to FDA | 1994-02-10 |
| Date Reported to Mfgr | 1994-02-04 |
| Date Added to Maude | 1994-03-09 |
| 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 |
| 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 | N/A |
| Generic Name | DRAINAGE BAG |
| Product Code | FON |
| Date Received | 1994-03-04 |
| Model Number | N/A |
| Catalog Number | 3T5904 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11882 |
| Manufacturer | PLASCO |
| Manufacturer Address | 3849 SWANSON COURT GURNEE IL 60031 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-03-04 |