FDA.reportPublic FDA data

MAUDE MDR 8279088

MDR report key
8279088
Report number
0001831750-2019-00027
Event key
0
Event type
3
Date of event
2018-10-01
Date received
2019-01-25
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#

Contact
MR. MARY KLAVER
Address
3800 EAST CENTRE AVENUE PORTAGE MI 49002 US
Phone
269-269-2693
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADEL OBS 6/04TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)STRYKER MEDICAL-KALAMAZOOHDD4700000000N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-250

Event Narratives#

N

Patient 1

THIS MDR IS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICE WAS NOT EVALUATED, AS THE ISSUE WAS IDENTIFIED AND RESOLVED DURING A TROUBLESHOOTING CALL BETWEEN THE CUSTOMER AND STRYKER TECHNICAL SUPPORT. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

D

Patient 1

THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE UNIT HAD REDUCED BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.