MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-12 for ULTRATHANE COPE NEPHROURETEROSTOMY SET N/A ULT8.5-8.5-28-NUCL-B-RH manufactured by Cook Inc.
[170525477]
Initial reporter occupation: sr. Clinical risk advisor. Report source-other: country of origin: (b)(6), mdip report. Pma/510(k) #: preamendment. (b)(4). 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
[170525478]
It was reported an unknown patient required placement of an ultrathane cope nephroureterostomy set in the bladder, ureter, and kidney for drainage. A day after placement, it was observed the "tube came apart at the tube/hub junction. " additionally, the device was leaking because the "tube was dislodged" from the hub. The device was successfully replaced with a new, similar device. No other adverse effects were reported for this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-03097 |
| MDR Report Key | 9460434 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-12 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-11-29 |
| Date Mfgr Received | 2020-03-24 |
| Date Added to Maude | 2019-12-12 |
| 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 | 2019-12-12 |
| Returned To Mfg | 2019-12-13 |
| Model Number | N/A |
| Catalog Number | ULT8.5-8.5-28-NUCL-B-RH |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Required No Informationntervention | 2019-12-12 |