FDA.reportPublic FDA data

MAUDE MDR 8281030

MDR report key
8281030
Report number
0001831750-2019-00114
Event key
0
Event type
3
Date of event
2018-10-01
Date received
2019-01-28
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
1STAIR PRO - MODEL 6252STRETCHER, HAND-CARRIEDSTRYKER MEDICAL-KALAMAZOOFPP6252000000N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-280

Event Narratives#

N

Patient 1

THIS MDR IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 19 DEVICES WERE EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED; 10 HAD BROKEN/DAMAGED COMPONENTS, 4 HAD WORN COMPONENTS, 2 HAD MISSING COMPONENTS, 1 HAD A BENT COMPONENT, 1 HAD A MISALIGNED COMPONENT AND 1 HAD A DIRTY COMPONENT. THE DEVICES WERE 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 20 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE TRACKS WERE DIFFICULT TO OPERATE OR WOULD NOT ENGAGE. THERE WAS NO PATIENT INVOLVEMENT.

N

Patient 1

IT WAS INITIALLY REPORTED THERE WERE 20 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE TRACKS WERE DIFFICULT TO OPERATE OR WOULD NOT ENGAGE. AFTER INVESTIGATION, 1 OF THE UNITS WAS FOUND TO NOT EXHIBIT THE REPORTED ISSUE, AND HAD NO DEFECTS OR MALFUNCTIONS. THEREFORE, THERE WERE ONLY 19 TOTAL EVENTS.

D

Patient 1

THIS REPORT SUMMARIZES 19 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE TRACKS WERE DIFFICULT TO OPERATE OR WOULD NOT ENGAGE. THERE WAS NO PATIENT INVOLVEMENT.