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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIOMENT CO., DRIVE MEDICAL; WHEELCHAIR
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ZHENJIANG ASSURE MEDICAL EQUIOMENT CO., DRIVE MEDICAL; WHEELCHAIR Back to Search Results
Model Number SSP218DDA-SF
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 03/10/2016
Event Type  Injury  
Event Description
Drive medical received a noticed of incident which involves the wheelchair that drive medical imports and distributes.Th patient was seen by the caregiver sitting on the edge of the bed with her legs extended over the arms of the wheelchair.Allegedly, the patient was trying to get out of the bed and into the wheelchair when her leg got caught by the armrest push button.The back of her leg was allegedly cut, and she lost a lot of blood.No product defect or other problems in the wheelchair has been reported to drive medical.This report is based on the information from the caregiver who is also the daughter of the patient.
 
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Brand Name
DRIVE MEDICAL
Type of Device
WHEELCHAIR
Manufacturer (Section D)
ZHENJIANG ASSURE MEDICAL EQUIOMENT CO.,
2 th nanwei road
zhenjiang, jiangsu 21200 0
CH  212000
MDR Report Key5564274
MDR Text Key42266970
Report Number2438477-2016-00018
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 Home Health Aide
Type of Report Initial
Report Date 04/08/2016,03/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Home Health Aide
Device Model NumberSSP218DDA-SF
Device Catalogue NumberSSP218DDA-SF
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/08/2016
Event Location Home
Date Report to Manufacturer04/08/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age79 YR
Patient Weight66
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