FDA.reportPublic FDA data

MAUDE MDR 8279087

MDR report key
8279087
Report number
0001831750-2019-00026
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
1TREATMENT RECLINERCHAIR, EXAMINATION AND TREATMENTSTRYKER MEDICAL-KALAMAZOOFRK3500000710Y Y

Patients#

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

Event Narratives#

N

Patient 1

THIS MDR IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE WAS EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED; THERE WAS A DISCONNECTED COMPONENT. THE DEVICE WAS REPAIRED AND RETURNED. 1 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 2 MALFUNCTION EVENT,S WHERE IT WAS REPORTED THE BACKREST BECAME DISCONNECTED FROM THE UNIT. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WERE NO CONSEQUENCES OR IMPACTS TO THE PATIENT.