MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-30 for URINARY DRAINAGE BAG WITH ANTIREFLUX TOWER * DYND15205 manufactured by Medline Industries.
[246466]
This was one of 4 events over a 3 month period in which the urinary drainage bag spontaneously ruptured in an area on the bottom of the bag near the drainage port. The age of the bags was between 1-2 weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024914 |
| MDR Report Key | 392953 |
| Date Received | 2002-04-30 |
| Date of Report | 2002-04-30 |
| Date Added to Maude | 2002-05-13 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URINARY DRAINAGE BAG WITH ANTIREFLUX TOWER |
| Generic Name | URINE DRAINAGE BAG |
| Product Code | EYZ |
| Date Received | 2002-04-30 |
| Model Number | * |
| Catalog Number | DYND15205 |
| Lot Number | 121501AZC01 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 381980 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | * MUNDELEIN IL 60060 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-04-30 |