MAUDE MDR 9213748

MDR report key
9213748
Report number
1820334-2019-02659
Event key
0
Event type
3
Date of event
2019-10-13
Date received
2019-10-21
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
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
1COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTSOQY INTRAUTERINE BALLOONCOOK INCOQYG24237J-SOSR-1005009656788Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-210

Event Narratives#

No narrative records found.