MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-07-24 for OPEN-END FLEXI-TIP URETERAL CATHETER 021305 manufactured by Cook Inc.
[114837942]
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
[114837943]
The user facility reported during a surgical cystoscopy procedure being performed on an (b)(6) year-old male patient, the open-end flexi-tip ureteral catheter broke inside the patient? S bladder. The fragment was retrieved with some sort of instrument during the initial surgery. There has been no report of any adverse effects to the patient due to this occurrence. Additional event, patient and device information has been requested from the user facility. No new information has been received at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02186 |
| MDR Report Key | 7713841 |
| Report Source | USER FACILITY |
| Date Received | 2018-07-24 |
| Date of Report | 2018-08-14 |
| Date of Event | 2018-06-26 |
| Date Mfgr Received | 2018-08-10 |
| Device Manufacturer Date | 2018-04-05 |
| Date Added to Maude | 2018-07-24 |
| 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 | 2018-07-24 |
| Returned To Mfg | 2018-07-30 |
| Catalog Number | 021305 |
| Lot Number | 8753553 |
| 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 | 2018-07-24 |