FDA.reportPublic FDA data

MAUDE MDR 988489

MDR report key
988489
Report number
988489
Event key
0
Event type
3
Date of event
2007-05-24
Date received
2007-08-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1JARITWEIGHTED SPECULUMJARIT SURGICALHDFUNKUNKUNKNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-08-2901. O

Event Narratives#

D

Patient 1

DURING PROCEDURE, WEIGHTED SPECULUM LACERATED PT'S VAGINA, REQUIRING SUTURING.