REWALK PERSONAL 50-20-0004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-08 for REWALK PERSONAL 50-20-0004 manufactured by Rewalk Robotics Ltd..

MAUDE Entry Details

Report Number3007615665-2016-00003
MDR Report Key6156331
Date Received2016-12-08
Date of Report2016-12-08
Date of Event2016-06-04
Date Facility Aware2016-11-08
Report Date2016-11-08
Date Reported to Mfgr2016-11-08
Date Mfgr Received2016-11-08
Device Manufacturer Date2015-09-29
Date Added to Maude2016-12-08
Event Key0
Report Source CodeDistributor report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ARI SOBEL
Manufacturer Street200 DONALD LYNCH BOULEVARD
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5082817271
Manufacturer G1REWALK ROBOTICS LTD.
Manufacturer Street3 HATNUFA ST. (6TH FLOOR)
Manufacturer CityYOKNE'AM, ISRAEL 2069203
Manufacturer CountryIS
Manufacturer Postal Code2069203
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameREWALK PERSONAL
Generic NamePOWERED EXOSKELETON
Product CodePHL
Date Received2016-12-08
Model NumberPERSONAL
Catalog Number50-20-0004
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerREWALK ROBOTICS LTD.
Manufacturer Address3 HATNUFA ST. (6TH FLOOR) YOKNE'AM, ISRAEL 2069203 IS 2069203



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