MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-06 for ULTRATHANE COPE NEPHROURETEROSTOMY SET N/A ULT10.2-10.2-22-NUCL-B-RH manufactured by Cook Inc.
[176053008]
Date of event: unknown. Pma/510(k) #: preamendment. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[176053009]
It was reported an unknown patient required the placement of an ultrathane cope nephroureterostomy set for an unknown procedure. The operator reported that after placement in the kidney/bladder, " the inner stylet was getting stuck in the drain. " the device was replaced with a device from the same lot number and experienced the same failure. No other adverse effects were reported for this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00063 |
| MDR Report Key | 9555288 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-06 |
| Date of Report | 2020-02-28 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-10-07 |
| Date Added to Maude | 2020-01-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRATHANE COPE NEPHROURETEROSTOMY SET |
| Generic Name | LJE CATHETER, NEPHROSTOMY |
| Product Code | LJE |
| Date Received | 2020-01-06 |
| Returned To Mfg | 2020-02-12 |
| Model Number | N/A |
| Catalog Number | ULT10.2-10.2-22-NUCL-B-RH |
| Lot Number | 10066116 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-06 |