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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRIVE DEVILBISS DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL

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DRIVE DEVILBISS DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL Back to Search Results
Device Problem Mechanical Problem (1384)
Patient Problem Bone Fracture(s) (1870)
Event Date 11/06/2023
Event Type  Injury  
Event Description
Drive devilbiss healthcare was served with a legal complaint regarding a "4-wheel walker with seat," which presumably refers to a rollator.The complaint alleges that the rollator's brakes failed, causing the end user to fall, hit her head, and sustain a left thumb proximal phalanx fracture.Drive is currently attempting, through counsel, 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 DEVILBISS HEALTHCARE
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
DRIVE DEVILBISS
99 seaview blvd.
port washington NY 11050
MDR Report Key18287174
MDR Text Key329995849
Report Number2438477-2023-00147
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 12/07/2023
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
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/07/2023
Distributor Facility Aware Date11/06/2023
Event Location Home
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/07/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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