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MAUDE MDR 584102

MDR report key
584102
Report number
MW1034964
Event key
0
Event type
3
Date of event
2005-02-15
Date received
2005-03-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
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
1KLEEN VAGINAL SPECULUMVAGINAL SPECULUMCARDINAL HEALTH CORPHDF*40755-025*NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-03-1501. R

Event Narratives#

D

Patient 1

AT COMPLETION OF A PAP SMEAR THE SPECULM COULD NOT BE CLOSED TO PROMOTE REMOVAL FROM THE VAGINA. THE DEVICE HAD TO BE DISMANTLED. PT HAD A SMALL AMOUNT OF BLEEDING.