FDA.reportPublic FDA data

MAUDE MDR 9638774

MDR report key
9638774
Report number
0001831750-2020-00263
Event key
0
Event type
3
Date of event
2020-01-01
Date received
2020-01-28
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. KRISTEN CANTER
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-KALAMAZOOFPP6252000000Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-280

Event Narratives#

N

Patient 1

THIS MDR IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. ONE DEVICE WAS NOT EVALUATED, AS THE ISSUE WAS IDENTIFIED AND RESOLVED DURING A TROUBLESHOOTING CALL BETWEEN THE CUSTOMER AND STRYKER TECHNICAL SUPPORT. ONE DEVICE WAS NOT MADE AVAILABLE FOR TESTING BY THE CUSTOMER; NO CAUSE WAS ESTABLISHED. 26 DEVICES WERE EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED; FIVE DEVICES HAD PEELING COMPONENTS, THREE DEVICES HAD MISSING COMPONENTS, SEVEN DEVICES HAD BROKEN/DAMAGED COMPONENTS, ONE DEVICE HAD A BENT COMPONENT, FOUR DEVICES HAD WORN COMPONENTS, ONE DEVICE HAD A LOOSE COMPONENT, ONE DEVICE HAD DETACHED COMPONENTS, TWO DEVICES HAD ALIGNMENT ISSUES, TWO DEVICES HAD DIRTY COMPONENTS, AND ONE DEVICE HAD A CRACKED COMPONENT. THE DEVICES WERE REPAIRED AND RETURNED. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

D

Patient 1

THIS REPORT SUMMARIZES 28 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICE WAS DIFFICULT TO MANEUVER. THERE WAS NO PATIENT INVOLVEMENT.