FDA.reportPublic FDA data

MAUDE MDR 319055

MDR report key
319055
Report number
MW1021256
Event key
0
Event type
3
Date received
2001-02-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VAGINALSPECULUMGALENICA, INC.HDF*8310*NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-02-210

Event Narratives#

D

Patient 1

LATCH DOES NOT STAY ENGAGED AFTER INSERTING.