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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX TRANSPORT 20 IN X 16 IN 9153637574 WHEELCHAIR, MECHANICAL

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INVAMEX TRANSPORT 20 IN X 16 IN 9153637574 WHEELCHAIR, MECHANICAL Back to Search Results
Model Number SOLARA3G
Device Problem Bent (1059)
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 forks are bent.

 
Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation. The result of the evaluation was that one of the forks had a 3/4 inch bend. , which confirmed the original complaint issue. However, the underlying cause could not be determined.

 
Event Description

The dealer stated the forks are bent.

 
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Brand NameTRANSPORT 20 IN X 16 IN 9153637574
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 Key5310713
MDR Text Key34355544
Report Number9616091-2015-02933
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
Remedial Action Replace
Type of Report Initial,Followup
Report Date 02/18/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/18/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberSOLARA3G
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/18/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2016
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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