MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-21 for ENTRA DILATION AND OCCLUSION CATHETER manufactured by American Medical Systems.
[5893]
Attempted stone basket extraction and during electrocautery four wires on the six wire basket melted necessitating an open proceure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16171 |
| MDR Report Key | 16171 |
| Date Received | 1994-07-21 |
| Date of Report | 1994-01-17 |
| Date of Event | 1994-01-11 |
| Date Facility Aware | 1994-01-24 |
| Report Date | 1994-01-27 |
| Date Reported to Mfgr | 1994-01-27 |
| Date Added to Maude | 1994-09-16 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTRA DILATION AND OCCLUSION CATHETER |
| Generic Name | URETHRAL BALLOON DILATION CATH W/STONE RETRIEVE |
| Product Code | HAM |
| Date Received | 1994-07-21 |
| ID Number | PRODUCT #72401270 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 36 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16104 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS |
| Manufacturer Address | 11001 BREN ROAD EAST MINNETONKA MN 55343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 10 | 1. Hospitalization; 2. Required No Informationntervention | 1994-07-21 |