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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 TREX20RP
Device Problems Bent (1059); Wheel (3130)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Dealer states the rear wheels are bent. He states it looks like the rims are warped.

 
Manufacturer Narrative

Product was returned for evaluation. The return fields in oracle state: standard wheelchairs. Assembly/component issue, box damage. New wheels returned out of round bent hand rim. Complaint was confirmed. The underlying cause could not be determined after reviewing the documentation in this investigation.

 
Event Description

Product was returned for evaluation. The return fields in oracle state: standard wheelchairs. Assembly/component issue, box damage. New wheels returned out of round bent hand rim. Dealer states the rear wheels are bent. He states it looks like the rims are warped.

 
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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 Key5328747
MDR Text Key34976315
Report Number9616091-2015-02963
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 02/05/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberTREX20RP
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/05/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2016
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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