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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL
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COM-DA HEALTHCARE CO.,LTD DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL Back to Search Results
Model Number R726BK
Device Problem Mechanical Problem (1384)
Patient Problem Bone Fracture(s) (1870)
Event Date 11/05/2023
Event Type  Injury  
Event Description
Drive devilbiss healthcare was notified of an incident involving a rollator by the end user, who reported that the front wheels continued to move while the brakes were locked.The end user did not fall, but reported that because she continued to hold onto the rollator when it was moving, she experienced a sharp pain in her previously replaced elbow and was diagnosed with a complex fracture and referred to an elbow specialist.Drive devilbiss healthcare is currently investigating the incident, however the end user refused to return 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)
COM-DA HEALTHCARE CO.,LTD
unit 3 no.94 dongcheng road,
dong sheng town
zhong shan city, guang dong province 52840 0
CH  528400
MDR Report Key18230791
MDR Text Key329278319
Report Number2438477-2023-00142
Device Sequence Number1
Product Code ITJ
UDI-Device Identifier00822383240664
UDI-Public822383240664
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 11/29/2023
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 NumberR726BK
Device Catalogue NumberR726BK
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/29/2023
Distributor Facility Aware Date11/07/2023
Event Location Home
Date Report to Manufacturer11/29/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/29/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age72 YR
Patient SexFemale
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