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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CC HSING COMPANY LIMITED DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL
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CC HSING COMPANY LIMITED DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL Back to Search Results
Model Number RTL10266CF
Device Problem Mechanical Problem (1384)
Patient Problem Laceration(s) (1946)
Event Date 10/19/2023
Event Type  Injury  
Event Description
Drive devilbiss healthcare was notified of an incident involving a rollator by the end user, who stated that the rear wheel fell off, causing her to fall and hit her shoulder and head on the kitchen table.Paramedics responded to the scene but the end user refused to go to the hospital.The end user was eventually diagnosed by her physician with a torn deltoid muscle in her left arm and an injury to her quadricep muscle, and is receiving physical therapy.Drive devilbiss is currently investigating the incident, including attempting to retrieve the device for evaluation.An update will be filed if additional information becomes available.
 
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Brand Name
DRIVE DEVILBISS HEALTHCARE
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
CC HSING COMPANY LIMITED
no. 1 benting
bentsuo village, sikao chiayi 26989 61
TW  2698961
MDR Report Key18291682
MDR Text Key330051603
Report Number2438477-2023-00148
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 12/08/2023
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 NumberRTL10266CF
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/08/2023
Distributor Facility Aware Date11/13/2023
Event Location Home
Date Report to Manufacturer12/08/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/08/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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