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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FORT METAL PLASTIC CO., LTD DRIVE; QUAD CANE
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FORT METAL PLASTIC CO., LTD DRIVE; QUAD CANE Back to Search Results
Model Number RTL10310
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes Fall (1848); Head Injury (1879)
Date of Event 05/19/2021
Type of Reportable Event Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a cane.We have not received the device for evaluation.We are filing this report in an over abundance of caution.We will file a follow up when additional data becomes known.End-user reported that the cane broke in half causing him to fall down 3 stairs hitting his head and hurting back.We are awaiting confirmation of medical service.
 
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Brand Name
DRIVE
Common Device Name
QUAD CANE
Manufacturer (Section D)
FORT METAL PLASTIC CO., LTD
yi he civil affairs
industrial area
guongdong 51602 3
CH  516023
MDR Report Key11917025
Report Number2438477-2021-00020
Device Sequence Number17193440
Product Code IPS
UDI-Device Identifier00822383254050
UDI-Public822383254050
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/01/2021
Report Date (Section F) 06/01/2021
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
Operator of Device Lay User/Patient
Device Model NumberRTL10310
Was the Report Sent to FDA? Yes
Device Age3 YR
Event Location Home
Date Report to Manufacturer06/03/2021
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/01/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age75 YR
Date Report Sent to FDA06/01/2021
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