N
Patient 1
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.
MAUDE MDR 9538388
- MDR report key
- 9538388
- Report number
- 1820334-2020-00022
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-12-17
- Date received
- 2020-01-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- UNK JENNIFER CANADA
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-02 | 0 |
Event Narratives#
D
Patient 1
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.