MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-10-08 for RUTNER SUPRAPUBIC BALLOON CATHETER SET G15261 081912 manufactured by Cook Inc.
[123203886]
(b)(6). (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
[123203887]
It was reported the rutner suprapubic balloon catheter was placed for percutaneous cystostomy, but the urine drainage was not confirmed next day. The customer found the catheter easily came off and the balloon was deflated. To find out what was the cause, he put the balloon into the water and attempted to inflate and confirmed the balloon would not inflate. He replaced it with another balloon. The patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03026 |
| MDR Report Key | 7942447 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-10-08 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-09-25 |
| Date Mfgr Received | 2018-10-31 |
| Device Manufacturer Date | 2018-01-16 |
| Date Added to Maude | 2018-10-08 |
| 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 | 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 | RUTNER SUPRAPUBIC BALLOON CATHETER SET |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2018-10-08 |
| Returned To Mfg | 2018-10-08 |
| Model Number | G15261 |
| Catalog Number | 081912 |
| Lot Number | NS8513221 |
| Device Expiration Date | 2019-07-16 |
| 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 | 2018-10-08 |