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 2019-05-15 for WHISTLE TIP URETERAL CATHETER G14030 022105 manufactured by Cook Inc.
[145167740]
Concomitant medical devices: laparoscope, electrosurgical unit, scissors, graspers, dissectors, coagulators. Pma/510k #: 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
[145167741]
It is reported a patient had a radical hysterectomy with bilateral oophorectomy and placement of bilateral cook whistle tip ureteral catheters. Two days later, urine leakage was observed. Three days after urine leakage was noted, it was arranged for the cook whistle tip ureteral catheters to be removed by a urologist. At this time it was found that one of the catheters was broken and a part was left inside the patient's body. An unspecified time period later, surgery was arranged to remove the retained section of the catheter. The patient's outcome was good. No additional consequences to the patient have been reported. Additional details regarding the patient and the event have been requested. At this time, no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01112 |
| MDR Report Key | 8613447 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-15 |
| Date of Report | 2019-07-12 |
| Date of Event | 2019-04-16 |
| Date Mfgr Received | 2019-06-23 |
| Device Manufacturer Date | 2019-01-10 |
| Date Added to Maude | 2019-05-15 |
| 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 | WHISTLE TIP URETERAL CATHETER |
| Generic Name | GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2019-05-15 |
| Returned To Mfg | 2019-05-09 |
| Model Number | G14030 |
| Catalog Number | 022105 |
| Lot Number | NS9435832 |
| 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. Other | 2019-05-15 |