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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL
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DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL Back to Search Results
Model Number R800KD-RD
Device Problem Mechanical Problem (1384)
Patient Problems Bruise/Contusion (1754); Head Injury (1879)
Event Date 10/03/2021
Event Type  Injury  
Event Description
Drive devilbiss healthcare was notified by a letter from an attorney of an incident involving a rollator which alleges that, "one of the two front wheels came off suddenly causing him to fall to the ground." the end user reinstalled the wheels and continued walking when another wheel fell off, causing the end user to fall.The end user tried to sit on the chair section of the rollator and fell over backwards.The end user sustained a head injury, neck sprain, back, knee and wrist contusion, bilateral knee effusions and exacerbation of condition that accelerated the need for a total knee replacement surgery.Drive devilbiss healthcare is currently investigating the incident, including attempting to inspect the product through the attorney.An update will be filed if additional information becomes available.
 
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Brand Name
DRIVE DEVILBISS HEALTHCARE
Type of Device
WALKER, MECHANICAL
MDR Report Key18758655
MDR Text Key336003302
Report Number2438477-2024-00008
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 Non-Healthcare Professional
Type of Report Initial
Report Date 02/22/2024
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? Yes
Device Operator Lay User/Patient
Device Model NumberR800KD-RD
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/22/2024
Distributor Facility Aware Date01/26/2024
Event Location Home
Date Report to Manufacturer02/22/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/22/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient SexMale
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