MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-30 for COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS J-SOSR-100500 manufactured by Cook Inc.
[98979003]
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
[98979004]
It was reported that the bakri balloon was missing a port on the stopcock that allows it to be a closed system. The bakri was used and filled with a syringe so there was no delay in patient care. There was no additional procedures required due to this occurrence. There were no adverse effects on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00252 |
| MDR Report Key | 7227049 |
| Date Received | 2018-01-30 |
| Date of Report | 2018-01-30 |
| Date of Event | 2016-09-27 |
| Date Mfgr Received | 2018-01-22 |
| Device Manufacturer Date | 2016-07-05 |
| Date Added to Maude | 2018-01-30 |
| 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 | 2018-01-30 |
| Catalog Number | J-SOSR-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 | 2018-01-30 |