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 2019-12-31 for URETERAL BALLOON DILATOR 010015 manufactured by Cook Inc.
[178334118]
(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
[178334119]
It was reported during an unspecified procedure using a ureteral balloon dilator to dilate a proximal ureteral stricture, the physician could not be certain that the second wire (the wire from the kit) was through the true lumen because placing that wire with a dual wire introducer created some contrast extravasation. Due to this, the physician had to abort the procedure and place a stent. No additional consequences to the patient have been reported. Additional details regarding the patient and procedure have been requested. At this time, no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-03175 |
| MDR Report Key | 9535955 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-31 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2019-12-31 |
| 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 | MRS. JENNIFER CANADA |
| 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 | 2019-12-31 |
| Catalog Number | 010015 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 1. Other; 2. Required No Informationntervention | 2019-12-31 |