MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2020-02-27 for COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS G24237 J-SOSR-100500 manufactured by Cook Inc.
[181960460]
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
[181960461]
It was reported, following a c-section and during the treatment of post partum hemorrhage using a cook bakri postpartum balloon with rapid instillation components, the balloon was leaking. Contraction treatment was attempted, but the situation did not improve. The blood loss volume after the time was abut 1200ml. The operator then placed a bakri device transabdominally, sutured the incision, and began to inflate the balloon. When the inflation volume reached 300ml liquid began flowing from the patient's vagina. The bakri was immediately removed, and a pinhole was noted at the bottom of he balloon material. Hemostasis was achieved by using another device. The blood loss during this time was about 100ml. According to the initial reported, there were no adverse effects to the patient due to the alleged malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00486 |
| MDR Report Key | 9764984 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2020-02-27 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2018-05-04 |
| Date Added to Maude | 2020-02-27 |
| 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 | MRS. 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 | 2020-02-27 |
| Returned To Mfg | 2020-03-19 |
| Model Number | G24237 |
| Catalog Number | J-SOSR-100500 |
| Lot Number | 8862762 |
| 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 | 2020-02-27 |