FDA.reportPublic FDA data

MAUDE MDR 2900753

MDR report key
2900753
Report number
2900753
Event key
0
Event type
3
Date of event
2012-12-28
Date received
2012-12-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1*CANNULA, SUCTION, UTERINEBUSSE HOSPITAL DISPOSABLESHGH*15366667-2 Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-12-310

Event Narratives#

D

Patient 1

THE PATIENT WAS IN THE OPERATING SUITE. THE UTERUS WAS SOUNDED AND THEN SUCTION CURETTE PLACED TO THE FUNDUS AND THEN ATTACHED TO SUCTION. THE TUBING ITSELF WAS COLLAPSING AND THEREFORE TECHNIQUE WAS CHANGED TO SHARP CURETTAGE. SHARP CURETTAGE WAS DONE TO VERIFY UTERUS WAS EMPTY.