MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-23 for BARDIAC URO SHEATH 1502 S;M, & L * manufactured by C.r. Bard, Inc.
[16785928]
Pt developed gangrene of penis after condom catheter was placed. Pt had partial penectomy on 4/26/97.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012349 |
| MDR Report Key | 127972 |
| Date Received | 1997-10-23 |
| Date of Report | 1997-10-10 |
| Date of Event | 1997-04-26 |
| Date Added to Maude | 1997-10-27 |
| 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 | BARDIAC URO SHEATH |
| Generic Name | CONDOM CATHETER |
| Product Code | EXJ |
| Date Received | 1997-10-23 |
| Model Number | 1502 S;M, & L |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 125220 |
| Manufacturer | C.R. BARD, INC |
| Manufacturer Address | 731 CENTRAL AVE MURRAY HILL NJ 07974 US |
| Baseline Brand Name | BARDIC URO-SHEATH |
| Baseline Generic Name | MALE EXTERNAL CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 1502M |
| Baseline ID | NA |
| Baseline Device Family | BARDIC URO-SHEATH |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K802433 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 1997-10-23 |