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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DANYANG JUMAO DRIVE MANUAL WHEELCHAIR

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DANYANG JUMAO DRIVE MANUAL WHEELCHAIR Back to Search Results
Model Number SSP218DDA-SF
Device Problem Material Integrity Problem (2978)
Patient Problems Contusion (1787); Bone Fracture(s) (1870); Laceration(s) (1946)
Event Date 09/30/2018
Event Type  Injury  
Event Description

Drive devilbiss healthcare is the initial importer of the device which is a wheelchair. End-user will not provide pms team with device until settlement is reached. The serial number he provided is not in our system. In an overabundance of caution we are filing this medwatch report. End-user was sitting at the table eating when the seat reportedly dropped through the frame. He advised that some of the upholstery screws were not properly threaded through the frame. He fell and suffered contusions and lacerations. He visited the doctor and was diagnosed with a fracture of the 11th vertebrae.

 
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Brand NameDRIVE
Type of DeviceMANUAL WHEELCHAIR
Manufacturer (Section D)
DANYANG JUMAO
36 danyan road,
danyang city
jiangsu provence, jiangsu 21230 0
CH 212300
MDR Report Key7958413
MDR Text Key123488636
Report Number2438477-2018-00052
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
Type of Report Initial
Report Date 10/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberSSP218DDA-SF
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/11/2018
Distributor Facility Aware Date09/30/2018
Device Age5 mo
Event Location Home
Date Report TO Manufacturer10/12/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/11/2018 Patient Sequence Number: 1
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