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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 Problems Disconnection (1171); Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The dealer states that the bolt that mounts the hinge assembly to the right cane has damaged threads and is allowing the bolt to completely slide out and not lock into place.The dealer has no further information to provide.
 
Manufacturer Narrative
Follow up to be sent if additional information is received.
 
Manufacturer Narrative
The device was evaluated by the returns department which found that the threads in the can base plate are stripped.
 
Event Description
The dealer states that the bolt that mounts the hinge assembly to the right cane has damaged threads and is allowing the bolt to completely slide out and not lock into place.The dealer has no further information to provide.
 
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Brand Name
TRANSPORT 20 IN X 16 IN 9153637574
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 Key4873854
MDR Text Key5864210
Report Number9616091-2015-01643
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,distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 08/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2015
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 Manufacturer08/07/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received08/07/2015
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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