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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZHONGSHAN LEBORN MEDICAL CO LTD DRIVE; COMMODE TRANSFER BENCH
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ZHONGSHAN LEBORN MEDICAL CO LTD DRIVE; COMMODE TRANSFER BENCH Back to Search Results
Model Number 12011KDC-1
Device Problem Material Integrity Problem (2978)
Patient Problems Fall (1848); Head Injury (1879); Neck Pain (2433)
Event Date 09/23/2019
Event Type  Injury  
Event Description
Drive devilbiss healthcare was notified of an incident involving a transfer bench by service of a lawsuit.The lawsuit alleges that while the patient was using the transfer bench, the leg broke, causing him to fall backwards and his neck to move forward.The end user alleges that a myriad of serious injuries, including quadriplegia, resulted from the accident, but information uncovered during the lawsuit has suggested that he was already quadriplegic and using a wheelchair prior to the accident.Drive is defending the lawsuit and is limited to the investigation possible through the lawsuit.
 
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Brand Name
DRIVE
Type of Device
COMMODE TRANSFER BENCH
Manufacturer (Section D)
ZHONGSHAN LEBORN MEDICAL CO LTD
chuang zhan road, xinsheng ind
dong chen rd.,dongsheng town
zhongshan, guangdong 52841 4
CH  528414
MDR Report Key17879577
MDR Text Key325024451
Report Number2438477-2023-00116
Device Sequence Number1
Product Code ILS
UDI-Device Identifier00822383231129
UDI-Public00822383231129
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number12011KDC-1
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/05/2023
Distributor Facility Aware Date07/27/2023
Event Location Home
Date Report to Manufacturer10/16/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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