MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-07 for OPEN-END URETERAL CATHETER 020015 manufactured by Cook Inc.
[132356751]
Pma/510(k) # : 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
[132356752]
It was reported that while a clinician was performing an unspecified procedure using a cook open-end ureteral catheter, the product broke in the bladder. According to the clinician all parts were retrieved. The product is no longer available for evaluation, but the packaging was kept. No adverse events have been reported as a result of the alleged malfunction. Additional information has been requested regarding the procedure, patient information including outcome, and concomitant devices. At the time of this report, no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00036 |
| MDR Report Key | 8223544 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-07 |
| Date of Report | 2019-02-04 |
| Date Mfgr Received | 2018-01-31 |
| Device Manufacturer Date | 2018-08-30 |
| Date Added to Maude | 2019-01-07 |
| 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 URETERAL CATHETER |
| Generic Name | GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2019-01-07 |
| Catalog Number | 020015 |
| Lot Number | 9130299 |
| 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 | 2019-01-07 |