MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-07 for BUSH SL URETERAL LIGHTED CATHETER SET J-BICS-058020 G16737 manufactured by Cook Medical.
[22998527]
Pt developed small blister on his leg after wires connecting the lighted ureteral stents burned into two pieces during a surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055364 |
| MDR Report Key | 5001520 |
| Date Received | 2015-08-07 |
| Date of Report | 2015-08-07 |
| Date of Event | 2015-08-05 |
| Date Added to Maude | 2015-08-13 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUSH SL URETERAL LIGHTED CATHETER SET |
| Generic Name | BUSH SL URETERAL LIGHTED CATHETER SET |
| Product Code | FCS |
| Date Received | 2015-08-07 |
| Model Number | J-BICS-058020 |
| Catalog Number | G16737 |
| Lot Number | 5798210 |
| Device Expiration Date | 2018-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-07 |