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 2019-03-12 for OPEN-END FLEXI-TIP URETERAL CATHETER G14521 021305 manufactured by Cook Inc.
[138802709]
Pma/510(k) #: pre-amendment. (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
[138802710]
It was reported the open end flexi tip ureteral catheter shattered during a case. An ellick evaluator was used to evacuate the pieces from the bladder. A new catheter to be used. There were no adverse effects to the patient as a result of this occurrence. Additional details have been requested. At the time of this report, no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00589 |
| MDR Report Key | 8413193 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-29 |
| Date of Event | 2019-03-04 |
| Date Mfgr Received | 2019-03-18 |
| Device Manufacturer Date | 2018-12-13 |
| Date Added to Maude | 2019-03-12 |
| 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 | MR. LARRY POOL |
| 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 | OPEN-END FLEXI-TIP URETERAL CATHETER |
| Generic Name | GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2019-03-12 |
| Model Number | G14521 |
| Catalog Number | 021305 |
| Lot Number | 9378692 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-03-12 |