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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX TREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553 WHEELCHAIR, MECHANICAL

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INVAMEX TREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553 WHEELCHAIR, MECHANICAL Back to Search Results
Model Number TREX2
Device Problems Frame (820); Out-Of-Box Failure (2311); Material Integrity Problem (2978); Wheel (3130)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Should additional information become available for the patient a supplemental record will be filed.

 
Event Description

All of the chairs arrived with the issue with the right rear wheel. The wheel and/or frame appears warped so that the chair feels wobbly and the wheel is hitting the side of the chair.

 
Manufacturer Narrative

(b)(4). The device in question was returned and a detailed evaluation has been performed on it. That evaluation confirmed that the wheelchair had wobbly right and left rear wheels. The underlying cause of the issue was not able to be determined.

 
Event Description

All of the chairs arrived with the issue with the right rear wheel. The wheel and/or frame appears warped, so that the chair feels wobbly and the wheel is hitting the side of the chair.

 
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Brand NameTREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553
Type of DeviceWHEELCHAIR, MECHANICAL
Manufacturer (Section D)
INVAMEX
parque industrial manimex
reynosa 88780
MX 88780
Manufacturer (Section G)
INVAMEX
parque industrial manimex
reynosa 88780
MX 88780
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5113105
MDR Text Key27187357
Report Number9616091-2015-02384
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 Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 10/20/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberTREX2
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/20/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2015
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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