MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-02 for RUTNER SUPRAPUBIC BALLOON CATHETER SET 081912 manufactured by Cook Inc.
[107190489]
Additional procedure was required this mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10
[107190490]
It was reported that sometime after placement of the rutner suprapubic balloon catheter, it began leaking at the connection between the catheter and inflation check valve. This device was removed and replaced with a renal pelvis balloon, but there were no further injuries aside from this additional procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01374 |
| MDR Report Key | 7481513 |
| Date Received | 2018-05-02 |
| Date of Report | 2018-05-02 |
| Date Mfgr Received | 2018-05-02 |
| Date Added to Maude | 2018-05-02 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RUTNER SUPRAPUBIC BALLOON CATHETER SET |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2018-05-02 |
| Catalog Number | 081912 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2018-05-02 |