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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AID-PRO HEALTHCARE CO., LTD. CAREX; ROLLATOR
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AID-PRO HEALTHCARE CO., LTD. CAREX; ROLLATOR Back to Search Results
Model Number FGA22100 0000
Device Problem Break (1069)
Patient Problems Bruise/Contusion (1754); Fall (1848)
Event Type  Injury  
Event Description
The frame broke at the weld of the rollator where the left front wheel is connected to the main frame.The user was leaving the hospital, and she was sitting on it with her daughter pushing her on tile flooring.The user fall and bruised the bones in her hand, and ended up in the er days later.The user had to have her hand in an elastic bandage and a splint.Compass health brands advised the user that a rollator user is not meant to sit on the rollator and be pushed around - the user stated she understood.
 
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Brand Name
CAREX
Type of Device
ROLLATOR
Manufacturer (Section D)
AID-PRO HEALTHCARE CO., LTD.
no. 58 yu long 3 road
dong sheng town
zhong shan city,
CH 
MDR Report Key7045861
MDR Text Key92528594
Report Number3012316249-2017-00132
Device Sequence Number1
Product Code ITJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Patient
Type of Report Initial
Report Date 11/20/2017
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 Patient Family Member or Friend
Device Model NumberFGA22100 0000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/20/2017
Distributor Facility Aware Date10/26/2017
Event Location Hospital
Date Report to Manufacturer11/20/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/20/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age67 YR
Patient Weight98
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