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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN DRIVE; WALKER/ROLLATOR
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UNKNOWN DRIVE; WALKER/ROLLATOR Back to Search Results
Device Problem Fracture (1260)
Patient Problems Fall (1848); Hip Fracture (2349)
Event Date 08/29/2020
Event Type  Injury  
Event Description
On december 10, 2021, a (b)(6) healthcare was served with a legal complaint regarding an incident that occurred on (b)(6) 2020 when the user "stood, and using the rollator walker with all due care, took a few steps when the shaft unexpectedly broke causing her to fall and sustain serious injuries and damages." the complaint states that the user sustained a hip injury.Drive is currently attempting to identify the product, including model and serial number, and investigate the incident, including an inspection of the product.Drive will file an update as soon as additional information becomes available.
 
Event Description
On december 10, 2021, a (b)(6) healthcare was served with a legal complaint regarding an incident that occurred on (b)(6) 2020 when the user "stood, and using the rollator walker with all due care, took a few steps when the shaft unexpectedly broke causing her to fall and sustain serious injuries and damages." the complaint states that the user sustained a hip injury.Drive is currently attempting to identify the product, including model and serial number, and investigate the incident, including an inspection of the product.Drive will file an update as soon as additional information becomes available.
 
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Brand Name
DRIVE
Type of Device
WALKER/ROLLATOR
Manufacturer (Section D)
UNKNOWN
MDR Report Key13502454
MDR Text Key285701062
Report Number2438477-2022-00003
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 01/24/2022
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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/24/2022
Distributor Facility Aware Date12/10/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/09/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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