MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2018-05-02 for RUTNER SUPRAPUBIC BALLOON CATHETER SET G15261 081912 manufactured by Cook Inc.
[107119467]
(b)(4). This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), 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
[107119468]
The complainant reported that the rutner suprapubic balloon catheter was placed percutaneously in the urinary bladder for a cystostomy. Approximately 7 days later, it was noticed that urine was not draining. Echographic examination confirmed that the catheter migrated, and the tip of the catheter was not placed inside the urinary bladder. The balloon was noted to be damaged when the physician removed the device. Another rutner suprapubic balloon catheter (unknown lot number) was placed instead. Aside from the additional procedure that was required to replace the device, there was no additional patient harm reported for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01349 |
| MDR Report Key | 7479556 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2018-05-02 |
| Date of Report | 2018-05-02 |
| Date of Event | 2015-11-10 |
| Date Mfgr Received | 2018-05-02 |
| Device Manufacturer Date | 2015-07-10 |
| 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 | 3 |
| Brand Name | RUTNER SUPRAPUBIC BALLOON CATHETER SET |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2018-05-02 |
| Model Number | G15261 |
| Catalog Number | 081912 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |