MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-01-02 for COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS G24237 J-SOSR-100500 manufactured by Cook Inc.
[178331398]
Occupation: pharmacien assistant specialiste. Pma/510k #: k170622. 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
[178331399]
It was reported, during treatment of post partum hemorrhage (pph) using a cook bakri postpartum balloon with rapid instillation components, the balloon deflated. After the bakri device was placed, the patient notified the medical team because she felt that something was falling out. The balloon had deflated and only 20ml of saline remained. The bleeding was already controlled, and there were no consequences to the patient. No additional procedures were required. No adverse effects were reported due to the alleged malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00022 |
| MDR Report Key | 9538388 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-01-03 |
| Device Manufacturer Date | 2019-07-25 |
| Date Added to Maude | 2020-01-02 |
| 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 | UNK JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| 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 | OQY INTRAUTERINE BALLOON |
| Product Code | OQY |
| Date Received | 2020-01-02 |
| Model Number | G24237 |
| Catalog Number | J-SOSR-100500 |
| Lot Number | 9903916 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-02 |