MAUDE MDR 8916504

MDR report key
8916504
Report number
1820334-2019-02063
Event key
0
Event type
3
Date received
2019-08-21
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
812-812-8123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BAKRI TAMPONADE BALLOON CATHETEROQY INTRAUTERINE BALLOONCOOK INCOQYUNKNOWNUNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-08-2101. H; 2. O

Event Narratives#

No narrative records found.