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 2018-02-23 for COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS J-SOSR-100500 manufactured by Cook Inc.
[100925225]
(b)(6). (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
[100925226]
It was reported during use of the cook bakri postpartum balloon with rapid instillation components the blue valve to open and close the plug fell off/broke somehow, so catheter couldn't be filled and they needed to use another catheter. No unintended part of this device remained inside the patient? S body. The patient did not require any additional procedures. As reported, the patient did not experience any adverse effects due to this occurrence. We have been advised the broken contaminated balloon was too bloody and dirty so the customer did not keep it for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00103 |
| MDR Report Key | 7291875 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-23 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-01-22 |
| Date Mfgr Received | 2018-04-06 |
| Device Manufacturer Date | 2017-10-12 |
| Date Added to Maude | 2018-02-23 |
| 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 | 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 | 2018-02-23 |
| 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 | 2018-02-23 |