MAUDE MDR 9172802

MDR report key
9172802
Report number
MW5090306
Event key
0
Event type
3
Date of event
2019-09-17
Date received
2019-10-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AMNISURE RAPID FETAL MEMBRANES RUPTURE TESTIMMUNOASSAY FOR DETECTION OF AMNIOTIC FLUID PROTEIN(S)QIAGENNQMFMRT1-2556304378I N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-0801. H

Event Narratives#

No narrative records found.