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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HL CORP DRIVE; KNEE WALKER
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HL CORP DRIVE; KNEE WALKER Back to Search Results
Model Number 790
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Laceration(s) (1946)
Date of Event 10/10/2018
Type of Reportable Event Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a knee walker.(b)(4) was notified of the incident through an attorney's letter.The unit was rented by the end-user.It had been previously rented 9 other times for a total usage of 279 days.End-user was using the unit when the seat post reportedly snapped and cut her inner thigh.We have no additional information.We will file a follow-up report when and if additional information becomes available.
 
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Brand Name
DRIVE
Common Device Name
KNEE WALKER
Manufacturer (Section D)
HL CORP
3rd industrial park
bitou village, song gangtown
baoan district, shenzhen, guangdong 51810 5
CH  518105
MDR Report Key8066650
Report Number2438477-2018-00059
Device Sequence Number19310448
Product Code ITJ
UDI-Device Identifier00822383183589
UDI-Public822383183589
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 11/13/2018
Report Date (Section F) 11/13/2018
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 Number790
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date10/16/2018
Event Location Other
Date Report to Manufacturer11/13/2018
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/13/2018
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 Required Intervention;
Date Report Sent to FDA11/13/2018
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