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 2018-12-09 for REWALK PERSONAL 50-20-0004 manufactured by Rewalk Robotics Ltd.

Event Text Entries

[129749687] The user broke his tibia, there is no additional data reported till now.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007615665-2018-00015
MDR Report Key8145104
Date Received2018-12-09
Date of Report2018-12-09
Date of Event2018-09-12
Date Facility Aware2018-09-12
Report Date2018-10-12
Date Reported to FDA2018-10-12
Date Reported to Mfgr2018-09-12
Date Mfgr Received2018-09-12
Device Manufacturer Date2016-12-15
Date Added to Maude2018-12-09
Event Key0
Report Source CodeDistributor report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ISHAY TAL
Manufacturer Street3 HATNUFA ST.
Manufacturer CityYOKNEAAM, 2069203
Manufacturer CountryIS
Manufacturer Postal2069203
Single Use3
Previous Use Code3
Removal Correction NumberZ-0944-2018
Event Type3
Type of Report0

Device Details

Brand NameREWALK PERSONAL
Generic NamePOWERED EXSOSKELETON, PRODUCT CODE: PHL
Product CodePHL
Date Received2018-12-09
Model NumberPERSONAL
Catalog Number50-20-0004
Device AvailabilityY
Device Age21 MO
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerREWALK ROBOTICS LTD
Manufacturer Address3 HATNUFA ST. (6TH FLOOR) YOKNE'AM 2069203, IS


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-12-09

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