MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-04-03 for FLEXI-TIP URETERAL CATHETER G14016 021105 manufactured by Cook Inc.
[140944534]
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
[140944535]
It was reported a strand of hair was found in the sealed packaging of the flexi-tip ureteral catheter. The device was not used. The procedure was successfully completed with another device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00650 |
| MDR Report Key | 8480618 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-03 |
| Date of Report | 2019-05-06 |
| Date of Event | 2019-03-19 |
| Date Mfgr Received | 2019-04-12 |
| Device Manufacturer Date | 2017-11-28 |
| Date Added to Maude | 2019-04-03 |
| 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 | FLEXI-TIP URETERAL CATHETER |
| Generic Name | GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2019-04-03 |
| Returned To Mfg | 2019-04-09 |
| Model Number | G14016 |
| Catalog Number | 021105 |
| Lot Number | 8400477 |
| 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 | 2019-04-03 |