MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-26 for BAKRI TAMPONADE BALLOON CATHETER J-SOS-100500 manufactured by Cook Vascular Inc.
[98973228]
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap(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
[98973229]
The complainant reported that the physician injected 300ml saline into the balloon and found that the liquid was leaking from the vagina. It was noted the balloon had been broken; the balloon was split longitudinally. There were no reported adverse effects to the patient as a result of the reported product problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00281 |
| MDR Report Key | 7222754 |
| Date Received | 2018-01-26 |
| Date of Report | 2018-01-26 |
| Date of Event | 2015-12-01 |
| Date Mfgr Received | 2018-01-22 |
| Device Manufacturer Date | 2014-12-29 |
| Date Added to Maude | 2018-01-26 |
| 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 | BAKRI TAMPONADE BALLOON CATHETER |
| Generic Name | KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC |
| Product Code | KNA |
| Date Received | 2018-01-26 |
| Catalog Number | J-SOS-100500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK VASCULAR INC |
| Manufacturer Address | 1186 MONTGOMERY LANE VANDERGRIFT PA 15690 US 15690 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-26 |