MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2020-02-26 for UNIVERSA SOFT URETERAL STENT SET G53711 US-726 manufactured by Cook Inc.
[181959691]
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
[181959692]
It was reported, when attempting to place a guide wire inside the universa soft ureteral stent during an unknown procedure, the stent was broken. They had to "replace the client for a new product. " according to the initial reported, there were no adverse effects to the patient due to this occurrence. Additional patient and event information has been requested. At this time, no further information is known. A follow up report will be submitted if additional details requested are received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00462 |
| MDR Report Key | 9756170 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER |
| Date Received | 2020-02-26 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2018-05-16 |
| Date Added to Maude | 2020-02-26 |
| 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 | UNIVERSA SOFT URETERAL STENT SET |
| Generic Name | FAD STENT, URETERAL |
| Product Code | FAD |
| Date Received | 2020-02-26 |
| Model Number | G53711 |
| Catalog Number | US-726 |
| Lot Number | 8888935 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-02-26 |