FDA.reportPublic FDA data

MAUDE MDR 7224118

MDR report key
7224118
Report number
1820334-2018-00284
Event key
0
Event type
3
Date of event
2016-02-23
Date received
2018-01-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. LARRY POOL
Address
750 DANIELS WAY BLOOMINGTON IN 47404 US
Phone
812-812-8128
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BAKRI TAMPONADE BALLOON CATHETERKNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGICCOOK INCKNAJ-SOS-100500R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-290

Event Narratives#

N

Patient 1

THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

D

Patient 1

THE FOLLOWING INFORMATION WAS REPORTED FOR A HEMOSTASIS PROCEDURE: THE USER INFLATED THE BALLOON WITH 50ML OF SALINE PRIOR TO PATIENT CONTACT AND DIDN'T FIND ANY DAMAGE IN THE BALLOON. THE BALLOON WAS DEFLATED AND INSERTED INTO THE PATIENT; THE BALLOON WAS INFLATED WITH APPROXIMATELY 150ML OF SALINE. THE BLEEDING STOPPED, BUT STARTED AGAIN AFTER APPROXIMATELY 2 HOURS SO THE BALLOON CATHETER WAS REMOVED. THE SAME BALLOON CATHETER WAS THEN REINSERTED AND THE BALLOON WAS INFLATED WITH APPROXIMATELY 120ML OF SALINE. THE CERVIX WAS PULLED WITH FORCEPS TO PERFORM LOCAL ANESTHESIA AND WATER CAME OUT WITH A SPLASHING SOUND. THE BALLOON CATHETER WAS REMOVED AND IT WAS NOTED THAT THE BALLOON HAD A TEAR THAT WAS APPROXIMATELY 5CM. ANOTHER DEVICE (SAME KIND) WAS PLACED IN THE PATIENT. THE USER NOTED THAT THE BALLOON DID NOT COME IN CONTACT WITH ANY HARD OBJECT AND THERE WAS NO DAMAGE ON THE BALLOON WHEN IT WAS INSERTED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED PRODUCT PROBLEM.