MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-20 for RUTNER SUPRAPUBIC BALLOON CATHETER SET UNKNOWN manufactured by Cook Inc.
[86746412]
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[86746413]
As reported by the physician of a (b)(6)-year-old female patient with multiple sclerosis, on (b)(6) 2017, the patient had a rutner suprapubic balloon catheter set placed. Per the physician, the device went in easily in the initial procedure. The balloon was inflated with 4 cc of sterile water, everything looked fine and the patient went home. Four days later, on (b)(6) 2017, the patient presented to the emergency room and was found with a belly full of urine. The emergency room doctor called the physician and reported the patient had a ruptured bladder. When the physician arrived at the hospital, the catheter had already been cut and discarded. It was determined the bladder had not ruptured. A tiny pinhole was found in the bladder. The physician believes the balloon deflated and the catheter came out of the hole. The general surgeon explored and found the opening in the bladder where the suprapubic tube entered the bladder. It was extraperitoneal, outside of the peritoneal sac. The opening into the bladder was about 2 mm in diameter. Repair was done to the bladder with no adverse effects to the patient. No portion of the device remained in the patient? S body. Additional patient, device and event information has been requested from the user facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-03239 |
| MDR Report Key | 6878981 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-09-20 |
| Date of Report | 2018-02-09 |
| Date of Event | 2017-09-01 |
| Date Mfgr Received | 2018-01-24 |
| Date Added to Maude | 2017-09-20 |
| 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 |
| 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 | 2017-09-20 |
| Catalog Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-09-20 |