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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRIVE; WALKER, MECHANICAL
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DRIVE; WALKER, MECHANICAL Back to Search Results
Model Number 796
Device Problem Unintended Movement (3026)
Patient Problem Non-union Bone Fracture (2369)
Event Date 11/12/2023
Event Type  Injury  
Event Description
Drive devilbiss healthcare was notified of an incident involving a knee walker by the end users' mother, who stated that the knee walker tiller spins 360 degrees while in use, causing the end user to fall three times.The final fall caused him to hit his head and re-injure his foot.He did not need any medical treatment to his head but was placed from a splint back into a boot for his foot.Drive is currently investigating the incident, including requesting the return of the device for evaluation, and an update will be filed if additional information becomes available.
 
Manufacturer Narrative
The manufacturer is unknown.
 
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Brand Name
DRIVE
Type of Device
WALKER, MECHANICAL
MDR Report Key18348084
MDR Text Key330770883
Report Number2438477-2023-00151
Device Sequence Number1
Product Code ITJ
UDI-Device Identifier50822383509346
UDI-Public50822383509346
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 12/18/2023
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 Number796
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2023
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/18/2023
Distributor Facility Aware Date12/08/2023
Event Location Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/18/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age9 YR
Patient SexMale
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