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 2018-05-03 for RUTNER SUPRAPUBIC BALLOON CATHETER SET G14920 081916 manufactured by Cook Urological Inc.
[107271494]
(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
[107271495]
It was reported that sometime after establishing a bladder fistula with the rutner suprapubic balloon catheter set, the balloon came off. The fistula was reestablished, but there were no further injuries aside from this additional procedure. No pieces of the complaint device were left in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01375 |
| MDR Report Key | 7484001 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-05-03 |
| Date of Report | 2018-05-03 |
| Date of Event | 2015-05-25 |
| Date Mfgr Received | 2018-05-02 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2018-05-03 |
| 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 | 2018-05-03 |
| Model Number | G14920 |
| Catalog Number | 081916 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL INC |
| Manufacturer Address | 1100 WEST MORGAN ST SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-03 |