MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,08 report with the FDA on 1997-06-09 for URINARY DRAINAGE BAG 390000 manufactured by Rusch Inc..
[63427]
The connector from the drainage bag to the catheter is leaking. No harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-1997-00052 |
| MDR Report Key | 97424 |
| Report Source | 04,05,08 |
| Date Received | 1997-06-09 |
| Date of Report | 1997-05-30 |
| Date of Event | 1997-05-01 |
| Date Mfgr Received | 1997-05-29 |
| Date Added to Maude | 1997-06-13 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URINARY DRAINAGE BAG |
| Generic Name | DRAINAGE BAG |
| Product Code | EYZ |
| Date Received | 1997-06-09 |
| Model Number | NA |
| Catalog Number | 390000 |
| Lot Number | 041096A |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 96140 |
| Manufacturer | RUSCH INC. |
| Manufacturer Address | 2450 MEADOWBROOK PARKEAY DULUTH GA 30136 US |
| Baseline Brand Name | URINARY DRAINAGE BAG |
| Baseline Generic Name | DRAINAGE BAG |
| Baseline Model No | NA |
| Baseline Catalog No | 390000 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-06-09 |