MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-12 for POLLACK OPEN-END FLEXITIP URETERAL CATHETER 021305 G14521 manufactured by Cook Inc..
[123833715]
A piece of the pollack catheter sheared off during case. It is believed that all pieces were removed from the pt. This is now the 3rd device issue with this product, we are looking to replace for safety and quality reasons.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080534 |
| MDR Report Key | 7964897 |
| Date Received | 2018-10-12 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-09-27 |
| Date Added to Maude | 2018-10-15 |
| 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 | RISK MANAGER |
| 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 | 0 |
| Brand Name | POLLACK OPEN-END FLEXITIP URETERAL CATHETER |
| Generic Name | URETERAL CATHETER, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2018-10-12 |
| Model Number | 021305 |
| Catalog Number | G14521 |
| Lot Number | 9048939 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Brand Name | POLLACK OPEN-END FLEXITIP URETERAL CATHETER |
| Generic Name | URETERAL CATHETER, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2018-10-12 |
| Model Number | 021305 |
| Catalog Number | G14521 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Brand Name | POLLACK OPEN-END FLEXITIP URETERAL CATHETER |
| Generic Name | URETERAL CATHETER, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2018-10-12 |
| Model Number | 021305 |
| Catalog Number | G14521 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | COOK INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-12 |