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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY ROSCOE K4 WHEELCHAIR
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JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY ROSCOE K4 WHEELCHAIR Back to Search Results
Model Number K41816DHFBSA
Device Problem Unstable (1667)
Patient Problems Fall (1848); Head Injury (1879)
Event Date 03/24/2017
Event Type  Injury  
Event Description
Customer is saying the upholstery on the back right side of the wheelchair is ripping away from the screw in the back and caused him to almost fall backwards.The patient's mother said this is the second chair this has happened to.The first one ripped on the left side the same way, and he did actually fall backwards, hitting his head and leaving a bump the size of a goose egg.
 
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Brand Name
ROSCOE K4 WHEELCHAIR
Type of Device
WHEELCHAIR
Manufacturer (Section D)
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY
yunyang industrial park
danyang city, jiangsu jiangsu 21230 0
CH  212300
MDR Report Key6499825
MDR Text Key73021159
Report Number3012316249-2017-00044
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 Patient Family Member or Friend
Type of Report Initial
Report Date 04/18/2017
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? Yes
Device Operator Lay User/Patient
Device Model NumberK41816DHFBSA
Device Catalogue NumberK41816DHFBSA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/18/2017
Distributor Facility Aware Date03/24/2017
Event Location Home
Date Report to Manufacturer04/18/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/18/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age25 YR
Patient Weight54
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