MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-01-20 for COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS G24237 J-SOSR-100500 manufactured by Cook Inc.
[177396326]
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
[177396327]
It was reported that a patient with history of a previous c-section had a cook bakri postpartum balloon with rapid instillation components placed due to uterine atony, but it was found to leaking after placement. Another cook bakri postpartum balloon with rapid instillation components was placed to achieve hemostasis. The patient lost 300 ml of blood before the bakri was placed. The patient was reported to be in good condition after the placement of the second bakri with an additional 10ml of blood loss after it's placement. During this delivery the patient also experienced an amniotic embolism that resulted in cardiac arrest (unrelated to the bakri).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00159 |
| MDR Report Key | 9607471 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-05-14 |
| Date Added to Maude | 2020-01-20 |
| 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 | 2020-01-20 |
| Returned To Mfg | 2020-01-27 |
| Model Number | G24237 |
| Catalog Number | J-SOSR-100500 |
| Lot Number | 9737098 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-20 |