MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2019-04-04 for URETERAL BALLOON DILATOR G14422 010015 manufactured by Cook Inc.
[141489457]
(b)(6). Occupation: non-healthcare professional. (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
[141489458]
It is reported while preparing for a ureteral balloon dilation using a cook ureteral balloon dilator, the physician opened the package and checked the integrity of the device by injecting the balloon. The physician detected the balloon had a leakage issue. This device was not used. The procedure was successfully completed with a flexor ureteral access sheath. The patient did not experience any adverse effects as a result of this alleged product malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00822 |
| MDR Report Key | 8485347 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2019-04-04 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-04-16 |
| Device Manufacturer Date | 2017-02-22 |
| Date Added to Maude | 2019-04-04 |
| 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 | URETERAL BALLOON DILATOR |
| Generic Name | EZN DILATOR, CATHETER, URETERAL |
| Product Code | EZN |
| Date Received | 2019-04-04 |
| Returned To Mfg | 2019-04-09 |
| Model Number | G14422 |
| Catalog Number | 010015 |
| Lot Number | 7698659 |
| 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 | 2019-04-04 |