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 2020-03-02 for ULTRAXX NEPHROSTOMY BALLOON AND SET UNBS-6-15 manufactured by Cook Inc.
[182926247]
Occupation: urology coordinator. 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
[182926248]
It was reported that during a pcnl (percutaneous nephrolithotomy ), a ultraxx nephrostomy balloon was inserted into a patient and inflated to 20 psi with 1/2 saline and 1/2 contrast when it burst. The balloon burst during the first time it was inflated. Another new balloon was used to complete the procedure. It was reported that no portion of the device remained inside the patient and that the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00524 |
| MDR Report Key | 9774816 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-09-18 |
| Date Added to Maude | 2020-03-02 |
| 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 | 2020-03-02 |
| Returned To Mfg | 2020-03-05 |
| Catalog Number | UNBS-6-15 |
| Lot Number | NS10022820 |
| 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 | 2020-03-02 |