MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-04-07 for BARDIC UROSHEATH UNK manufactured by C.r. Bard, Inc..
[15607559]
Pt developed gangrene while urosheath was in use at a nursing home. Spoke with person on 3-23-00 who advised the co that this person had been hired as an expert witness in pending litigation case concerning nursing home pt who had penile amputation as a result of gangrene associated with condom catheter use. Reporter stated pt. May have pulled strap, thus causing problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2000-00013 |
| MDR Report Key | 272644 |
| Report Source | 00 |
| Date Received | 2000-04-07 |
| Date of Report | 2000-04-07 |
| Date of Event | 1999-01-08 |
| Date Mfgr Received | 2000-03-24 |
| Date Added to Maude | 2000-04-11 |
| 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 |
| Manufacturer Contact | VIVIAN STEPHENS |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846902 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARDIC UROSHEATH |
| Generic Name | CONDOM CATHETER |
| Product Code | EXJ |
| Date Received | 2000-04-07 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 263948 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2000-04-07 |