MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-02-21 for COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS J-SOSR-100500 manufactured by Cook Inc.
[100783640]
(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[100783641]
It was reported the female patient was treated for post-partum hemorrhage using an inflated cook bakri postpartum balloon. As reported, the catheter was unable to be deflated by withdrawing water from the three-way tap. The three-way tap port was removed so the bakri could be deflated. The patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00456 |
| MDR Report Key | 7286634 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-21 |
| Date of Report | 2018-05-03 |
| Date of Event | 2018-01-18 |
| Date Mfgr Received | 2018-04-26 |
| Device Manufacturer Date | 2017-10-12 |
| Date Added to Maude | 2018-02-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS |
| Generic Name | KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC |
| Product Code | KNA |
| Date Received | 2018-02-21 |
| Catalog Number | J-SOSR-100500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-02-21 |