FDA.reportPublic FDA data

MAUDE MDR 8554781

MDR report key
8554781
Report number
0001831750-2019-00349
Event key
0
Event type
3
Date of event
2019-01-01
Date received
2019-04-26
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, DIALYSIS, UNPOWERED, WITHOUT SCALESSTRYKER MEDICAL-KALAMAZOOFIA3500000710Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-260

Event Narratives#

N

Patient 1

THIS MDR IS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICE WAS EVALUATED IN THE FIELD BUT THE ISSUE WAS NOT CONFIRMED; NO DEFECT OR MALFUNCTION WAS FOUND. 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 FOOTEND DID NOT ALWAYS LATCH. THERE WAS NO PATIENT INVOLVEMENT.