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 2020-01-13 for BAKRI TAMPONADE BALLOON CATHETER G30673 J-SOS-100500 manufactured by Cook Inc.
[177838390]
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
[177838391]
It was reported, while attempting to treat post partum hemorrhage following a cesarean section using a bakri tamponade balloon catheter, the balloon was leaking. The operator tested the device prior to use and discovered the balloon to be leaking. Another bakri device was used and hemostasis was successfully achieved. No adverse effects have been reported due to the alleged malfunction. Additional patient and event details have been requested. At this time, no additional information is known. A follow up report will be submitted with any additional details that are received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00096 |
| MDR Report Key | 9580286 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-12-21 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2019-07-10 |
| Date Added to Maude | 2020-01-13 |
| 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 | BAKRI TAMPONADE BALLOON CATHETER |
| Generic Name | OQY INTRAUTERINE BALLOON |
| Product Code | OQY |
| Date Received | 2020-01-13 |
| Returned To Mfg | 2020-01-27 |
| Model Number | G30673 |
| Catalog Number | J-SOS-100500 |
| Lot Number | 9869288 |
| 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 | 2020-01-13 |