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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD DRIVE MEDICAL; WHEELCHAIR, MECHANICAL
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ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD DRIVE MEDICAL; WHEELCHAIR, MECHANICAL Back to Search Results
Model Number CX418ADFA-ELR
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 12/01/2016
Event Type  Injury  
Event Description
(b)(4) received notice regarding the incident from the insurance adjuster company (b)(6), involving a wheelchair, a product imported and distributed by (b)(4).While sitting in the wheelchair the enduser lean to one side to get something, when one of the wheels allegedly came off causing the enduser to fall out of the wheelchair.Allegedly a screw placed on her femur prior to incident broke and came off causing the plate to shift.She had surgery to correct the shifted plate and screws.According to the complaint, the enduser's son had repaired the wheelchair in the past.This report is based on the information that was provided by (b)(6).
 
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Brand Name
DRIVE MEDICAL
Type of Device
WHEELCHAIR, MECHANICAL
Manufacturer (Section D)
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD
2 th nanwei road
zhenjiang jiangsu, 21200 0
CH  212000
MDR Report Key6491602
MDR Text Key72778709
Report Number2438477-2017-00034
Device Sequence Number1
Product Code IOR
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 04/13/2017,03/15/2017
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
Device Operator Lay User/Patient
Device Model NumberCX418ADFA-ELR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/13/2017
Distributor Facility Aware Date03/15/2017
Device Age2 YR
Event Location Home
Date Report to Manufacturer04/13/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/13/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient Weight92
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