MAUDE MDR 9699149

MDR report key
9699149
Report number
1820334-2020-00330
Event key
0
Event type
3
Date received
2020-02-12
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
MRS. JENNIFER CANADA
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-10050010073070R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-120

Event Narratives#

No narrative records found.