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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRIVE MEDICAL CANADA, INC. ROLLATOR; WALKER, MECHANICAL
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DRIVE MEDICAL CANADA, INC. ROLLATOR; WALKER, MECHANICAL Back to Search Results
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Event or Problem Description
A reporter called to report her hand rollator has manufacturer defect.She said the back wheel has brakes but the front wheel does not.The front wheels roll on their own and it is not safe to use the rollator because there is a fall risk.She went on saying that she stopped using the device because it is not safe to use it.
 
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Brand Name
ROLLATOR
Common Device Name
WALKER, MECHANICAL
Manufacturer (Section D)
DRIVE MEDICAL CANADA, INC.
MDR Report Key12302519
Report NumberMW5103128
Device Sequence Number18413666
Product Code ITJ
Initial Reporter StateVA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Operator of Device No Information
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/05/2021
Patient Sequence Number1
Patient Weight122
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