FDA.reportPublic FDA data

MAUDE MDR 1056864

MDR report key
1056864
Report number
MW5007175
Event key
0
Event type
3
Date of event
2008-05-22
Date received
2008-06-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SANI-SPECVAGINAL SPECULUMLEISEGANG MEDICALHDF82329NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-06-040

Event Narratives#

D

Patient 1

RN EXPERIENCED DIFFICULTY UNLOCKING SPECULUM FOR REMOVAL AFTER EXAM.