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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUROCARE INNOVATION CO., LTD. TRANSPORT CHAIR; WHEELCHAIR/TRANSPORT CHAIR
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EUROCARE INNOVATION CO., LTD. TRANSPORT CHAIR; WHEELCHAIR/TRANSPORT CHAIR Back to Search Results
Model Number FGA22600 0000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Head Injury (1879)
Event Type  Injury  
Event Description
The user was sitting in the transport chair on a bus.The user reported that the driver on the bus attached the transport chair with the user in the chair - the driver stopped at a red light and then took off at a green light, when the user flipped back, slid to the back of the bus and hit her head.The user is ok.The user's daughter was with her, and does not think that the user was hooked up properly in the vehicle - information provided regarding the chair being attached on the bus with four straps to anchor it during transportation.The user does not have any cuts or anything, however, the driver called an ambulance.
 
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Brand Name
TRANSPORT CHAIR
Type of Device
WHEELCHAIR/TRANSPORT CHAIR
Manufacturer (Section D)
EUROCARE INNOVATION CO., LTD.
no. 1 qianan rd. dianshanhu to
kunshan city, jiangsu,
CH 
MDR Report Key5570963
MDR Text Key42440608
Report Number2182780-2016-00004
Device Sequence Number1
Product Code IOR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/21/2016,04/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberFGA22600 0000
Device Catalogue NumberA226-00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/21/2016
Distributor Facility Aware Date03/17/2016
Event Location Other
Date Report to Manufacturer04/12/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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