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 2020-03-13 for ULTRAXX NEPHROSTOMY BALLOON AND SET UNBS-10-15-CS manufactured by Cook Inc.
[183355054]
Occupation: other non-healthcare professional: buyer. 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
[183355055]
It was reported, during a percutaneous nephrolithotomy (pcnl) using a ultraxx nephrostomy balloon and set, the stopcock was letting out pressure and fluid. When starting to inflate the balloon, the stopcock was letting out pressure and fluids (1/2 contrast and 1/2 saline). The stopcock was leaking where it tightens to the catheter. The balloon was inflated/deflated two times. The stopcock was then removed and the inflation device was connected directly to the balloon without the stopcock. The procedure was successfully completed. According to the initial reporter, the patient did not experience any adverse effects due to the alleged malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00607 |
| MDR Report Key | 9831048 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-13 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2020-01-06 |
| Date Added to Maude | 2020-03-13 |
| 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 | ULTRAXX NEPHROSTOMY BALLOON AND SET |
| Generic Name | LJE CATHETER, NEPHROSTOMY |
| Product Code | LJE |
| Date Received | 2020-03-13 |
| Returned To Mfg | 2020-03-19 |
| Catalog Number | UNBS-10-15-CS |
| Lot Number | 10246282 |
| 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 | 2020-03-13 |