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 Inc.
[98781932]
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
[98781933]
It was reported that when the physician injected 300ml saline into the balloon, the fluid began to leak from the vagina, so the balloon was removed and found to be ruptured longitudinally. There were no injuries or additional procedures, and no pieces of the device were left inside the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00280 |
| MDR Report Key | 7222248 |
| Date Received | 2018-01-26 |
| Date of Report | 2018-01-26 |
| Date of Event | 2015-12-03 |
| Date Mfgr Received | 2018-01-22 |
| Device Manufacturer Date | 2015-01-11 |
| 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 INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-26 |