MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-07-29 for URETERAL DRAINAGE BAG WITH URETERAL CATHETER CONNECTOR * 7000 manufactured by Portex.
[289451]
Device leaks after 3 days. The leak is at the seal at bottom of bag where bag is drained. Rptr feels they are defective. Six bags were involved. Rptr also was informed by hosp that other pts have had problems too. Mfr was notified and rptr was asked to send bag to them but the bag had been altered by rptr so mfr was unable to do anything. Rptr is concerned that mfr is not going to do anything to remedy problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025684 |
| MDR Report Key | 407843 |
| Date Received | 2002-07-29 |
| Date of Report | 2002-07-29 |
| Date of Event | 2002-07-08 |
| Date Added to Maude | 2002-08-01 |
| 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 | URETERAL DRAINAGE BAG WITH URETERAL CATHETER CONNECTOR |
| Generic Name | URETERAL DRAINAGE BAG |
| Product Code | EXG |
| Date Received | 2002-07-29 |
| Model Number | * |
| Catalog Number | 7000 |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 396826 |
| Manufacturer | PORTEX |
| Manufacturer Address | * KEENE NH 03431 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-07-29 |