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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX SOLARA 3G LTD 20W 24 COM 9153653250 WHEELCHAIR, MECHANICAL

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INVAMEX SOLARA 3G LTD 20W 24 COM 9153653250 WHEELCHAIR, MECHANICAL Back to Search Results
Model Number SOLARA3G
Device Problems Bent (1059); Device Subassembly (3051)
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 that the fork is bent not sure how.

 
Manufacturer Narrative

Product was returned for evaluation. The return fields in oracle state: standard wheelchairs. Other, other/defective. Fork bent on top at bolt entry: only fork in box. 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. Other, other/defective. Fork bent on top at bolt entry: only fork in box. Dealer states that the fork is bent not sure how.

 
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Brand NameSOLARA 3G LTD 20W 24 COM 9153653250
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 Key5343031
MDR Text Key35330636
Report Number9616091-2016-00005
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 01/27/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/05/2016
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 Manufacturer01/27/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2016
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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