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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX 9XT SWINGAWAY FRAME STYLE 9153629153; WHEELCHAIR, MECHANICAL

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INVAMEX 9XT SWINGAWAY FRAME STYLE 9153629153; WHEELCHAIR, MECHANICAL Back to Search Results
Model Number 9XDT
Device Problems Out-Of-Box Failure (2311); Deformation Due to Compressive Stress (2889)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow up will be sent if the product or additional information is obtained.
 
Event Description
Dealer advised upper left second hole down is off center causing the back upholstery to buckle out of the box.
 
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Brand Name
9XT SWINGAWAY FRAME STYLE 9153629153
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 Key4956627
MDR Text Key23141411
Report Number9616091-2015-01954
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
Report Date 07/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number9XDT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/08/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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