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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: A & I INDUSTRIES LTD DRIVE; ROLLATOR
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A & I INDUSTRIES LTD DRIVE; ROLLATOR Back to Search Results
Model Number 795B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fracture, Arm (2351)
Event Type  Injury  
Event Description
(b)(4) is the initial importer of the device which is a rollator.Consumer reportedly slid off the seat and broke her arm because the "footrest flipped backwards".Our tech support has advised that the proper use of the device would require the user to rest their feet on the footrest while in motion.The footrests cannot flip backwards in this instance.If the user was standing on the footrest to exit the device the device would flip forward and jostle the user.This is not recommended.We await return of the device for evaluation.
 
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Brand Name
DRIVE
Type of Device
ROLLATOR
Manufacturer (Section D)
A & I INDUSTRIES LTD
lian du industry park
le liu town, shunde district
foshan city,
CH 
MDR Report Key8824425
MDR Text Key152161931
Report Number2438477-2019-00042
Device Sequence Number1
Product Code ITJ
UDI-Device Identifier00822383213484
UDI-Public822383213484
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number795B
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/24/2019
Distributor Facility Aware Date06/20/2019
Device Age6 MO
Date Report to Manufacturer07/25/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight61
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