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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE; CANE SEAT
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COM-DA HEALTHCARE CO.,LTD DRIVE; CANE SEAT Back to Search Results
Model Number RTL10365-ADJ
Medical Device Problem Code Break (1069)
Health Effect - Clinical Codes Fall (1848); Head Injury (1879)
Date of Event 10/29/2022
Type of Reportable Event Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving an adjustable cane seat by an end user, who stated that the seat detached from the unit and caused him to fall backwards and hit his head on the concrete ground.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.
 
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Brand Name
DRIVE
Common Device Name
CANE SEAT
Manufacturer (Section D)
COM-DA HEALTHCARE CO.,LTD
no. 1, jinzhao street, west di
no. 6 workshop ii
zhongshan city, guangdong
CH 
MDR Report Key15833579
Report Number2438477-2022-00114
Device Sequence Number14752608
Product Code INP
UDI-Device Identifier00822383246123
UDI-Public00822383246123
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/21/2022
Report Date (Section F) 11/21/2022
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? Yes
Operator of Device Lay User/Patient
Device Model NumberRTL10365-ADJ
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date11/02/2022
Device Age1 YR
Event Location Other
Date Report to Manufacturer11/28/2022
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/21/2022
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient SexMale
Patient Weight107 KG
Date Report Sent to FDA11/21/2022
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