MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-23 for CYSTOFLO II URINARY DRAINAGE BAG * 2D2577V manufactured by Baxter Healthcare Corp. Renal Div..
[37578]
Pt reports last 3 urinary bags leak near clamp location.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010450 |
| MDR Report Key | 57606 |
| Date Received | 1996-12-23 |
| Date of Report | 1996-12-20 |
| Date of Event | 1996-10-20 |
| Date Added to Maude | 1996-12-26 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | CYSTOFLO II URINARY DRAINAGE BAG |
| Generic Name | URINARY DRAINAGE BAG |
| Product Code | EYZ |
| Date Received | 1996-12-23 |
| Model Number | * |
| Catalog Number | 2D2577V |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 58096 |
| Manufacturer | BAXTER HEALTHCARE CORP. RENAL DIV. |
| Manufacturer Address | 1620 WAUKEGAN RD MCGAW PARK IL 600856730 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-12-23 |