MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-10-30 for DOUBLE J STENT manufactured by Unknown.
[15258360]
Pre-op diagnosis = carcinoma of the prostate with bilateral stents. Post-op = left stent easily replaced. Right stent was broken in 2 pieces, was in the ureter, & unable to be removed. Unknown as to when stents were placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 27939 |
| MDR Report Key | 27939 |
| Date Received | 1995-10-30 |
| Date of Report | 1995-10-20 |
| Date of Event | 1995-09-18 |
| Date Facility Aware | 1995-09-18 |
| Report Date | 1995-10-20 |
| Date Added to Maude | 1995-11-09 |
| 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 | DOUBLE J STENT |
| Generic Name | DOUBLE J STENT |
| Product Code | MER |
| Date Received | 1995-10-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 28842 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1995-10-30 |