MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-12 for COOK G14430 020116 manufactured by Cook Incorporated.
[75004874]
Patient Sequence No: 1, Text Type: N, H10
[75004875]
Ureteral stents placed by the urologist prior to total abdominal hysterectomy (tah). After completion of the tah the bilateral stents were removed by the ob/gyn. It was noted upon inspection that the right ureter stent was not completely removed. Abdominal ct confirmed retention of a portion of the stent. Pt. Returned to operating room and retained piece removed without difficulty. Per urologist's, "reasons of that fracture of ureteral catheter are unknown. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6562731 |
| MDR Report Key | 6562731 |
| Date Received | 2017-05-12 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-05-02 |
| Report Date | 2017-05-11 |
| Date Reported to FDA | 2017-05-11 |
| Date Reported to Mfgr | 2017-05-11 |
| Date Added to Maude | 2017-05-12 |
| 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 | 3 |
| 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 | COOK |
| Generic Name | CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Product Code | EYB |
| Date Received | 2017-05-12 |
| Model Number | G14430 |
| Catalog Number | 020116 |
| Lot Number | 618205 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INCORPORATED |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-12 |