MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-25 for COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS J-SOSR-100500 manufactured by Cook Inc.
[98524878]
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
[98524879]
It was reported that bakri post-partum balloon deflated during use and was removed. The indication was status post c-section with post-partum hemorrhaging. The physician filled the balloon with 240ml and closed the uterus. The staff noticed the balloon was deflated and removed it. It was reported that the balloon was split or had a slice on the side of the balloon causing it to deflate. There was no reported harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00245 |
| MDR Report Key | 7219291 |
| Date Received | 2018-01-25 |
| Date of Report | 2018-01-25 |
| Date Mfgr Received | 2018-01-22 |
| Device Manufacturer Date | 2014-12-04 |
| Date Added to Maude | 2018-01-25 |
| 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 | COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS |
| Generic Name | KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC |
| Product Code | KNA |
| Date Received | 2018-01-25 |
| Catalog Number | J-SOSR-100500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-01-25 |