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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 TREX20RFP
Device Problems Bent (1059); Out-Of-Box Failure (2311)
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
The dealer stated the chair arrived with both seat rails bent out of box.
 
Manufacturer Narrative
Product was returned for evaluation.The return fields in oracle state: standard wheelchairs.Frame, bent frame.Both seat rails are bent won't fit h blocks both rear wheels the bearings are squeaking.Product received expanded evaluation.The expanded evaluation report states: visual inspection- the cross brace was in good condition, but the seat rails were bent such that they did not align with the h-blocks correctly.The seat upholstery sagged due to the bent seat rails.Conclusions- utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the tracer ex2 wheelchair of having bent seat rails.Complaint of "seat rails bent " 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.Frame, bent frame.Both seat rails are bent won't fit h blocks both rear wheels the bearings are squeaking.Product received expanded evaluation.The expanded evaluation report states: visual inspection- the cross brace was in good condition, but the seat rails were bent such that they did not align with the h-blocks correctly.The seat upholstery sagged due to the bent seat rails.Conclusions- utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the tracer ex2 wheelchair of having bent seat rails.The dealer stated the chair arrived with both seat rails bent out of box.
 
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Brand Name
TREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553
Type of Device
WHEELCHAIR, 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 Key5064529
MDR Text Key25892519
Report Number9616091-2015-02220
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 11/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberTREX20RFP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/13/2015
Initial Date FDA Received09/09/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/03/2015
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
Patient Sequence Number1
Patient Outcome(s) Other;
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