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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUROCARE INNOVATION CO LTD CAREX; TRANSPORT CHAIR
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EUROCARE INNOVATION CO LTD CAREX; TRANSPORT CHAIR Back to Search Results
Model Number FGA33677 0000
Device Problems Device Inoperable (1663); Noise, Audible (3273)
Patient Problems Bruise/Contusion (1754); Fall (1848); Pain (1994)
Event Date 12/22/2017
Event Type  Injury  
Event Description
The end-user's daughter states that the wheels were in a locked position but the transport chair kept moving.She states the back wheels don't lock even when they are locked and they make a grating noise and all four wheels do not make complete contact with the floor as there are divots in the wheels.The daughter took the end-user to the emergency room as she hurt her left hip when she fell.The daughter states she had a bruised hip that went all the way to the bone.The daughter states that the fall started a course of medical issues that resulted in her staying in the hospital.Her mother has been in the hospital because of other health issues and is now getting ready to come home.She had physical therapy while she was in the hospital.
 
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Brand Name
CAREX
Type of Device
TRANSPORT CHAIR
Manufacturer (Section D)
EUROCARE INNOVATION CO LTD
no. 1 qianan rd.
dianshanhu town
kunshan city, jiangsu,
CH 
MDR Report Key7457705
MDR Text Key106407400
Report Number3012316249-2018-00022
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 04/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberFGA33677 0000
Device Catalogue NumberA336-77
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/25/2018
Distributor Facility Aware Date04/04/2018
Device Age20 MO
Event Location Home
Date Report to Manufacturer04/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age68 YR
Patient Weight45
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