FDA.reportPublic FDA data

MAUDE MDR 8531010

MDR report key
8531010
Report number
8531010
Event key
0
Event type
3
Date of event
2019-02-22
Date received
2019-04-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
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
1KIWI? OMNICUP?EXTRACTOR, VACUUM, FETALCLINICAL INNOVATIONS, LLCHDBVAC-6000MT* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-190

Event Narratives#

D

Patient 1

MEDICAL DOCTOR NOTED HANDLE WAS HALF DISCONNECTED FROM SUCTION DEVICE, EXPOSING A SPRING THAT WAS NOT FIXED AND COULD HAVE BEEN DROPPED AS A FOREIGN OBJECT INTO THE SURGICAL FIELD. DEVICE WAS NOT FUNCTIONAL.