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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX MANUFACTURING MYON SWINGAWAY WHEELCHAIR; WHEELCHAIR, MECHANICAL

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INVAMEX MANUFACTURING MYON SWINGAWAY WHEELCHAIR; WHEELCHAIR, MECHANICAL Back to Search Results
Model Number NA:MYON
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Fall (1848)
Event Date 09/06/2018
Event Type  Injury  
Manufacturer Narrative
Invacare was made aware of this event which occured in the (b)(6) involving an action3 ng sp wheelchair which was manufactured by invacare (b)(4).Invacare is filing this report because the myon wheelchair, made at invacare owned invamex and sold in the us has been determined to be similar in design to the action3 ng sp.The client stated that when propelling (foot propels using right foot and right hand) through the living room the bolt came out of the top hole on castor assembly and the castor assembly rotated back under the chair causing the client to fall from the chair landing on the side affected by a previous stroke.The client injured their ribs requiring antibiotics and pain medication invacare (b)(4) has requested the action3 ng sp wheelchair be returned but have not received it as of the date of this filing.If more information is received a follow-up will be submitted.
 
Event Description
The end user stated that when propelling through living room the bolt came out of the top hole of the castor assembly.The castor assembly flipped back under the chair causing the client to fall from the chair injuring his rib.
 
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Brand Name
MYON SWINGAWAY WHEELCHAIR
Type of Device
WHEELCHAIR, MECHANICAL
Manufacturer (Section D)
INVAMEX MANUFACTURING
102 parque industrial manimex
reynosa, tamaulipas 88780
MX  88780
Manufacturer (Section G)
INVAMEX MANUFATURING
102 parque industrial manimex
reynosa, tamaulipas 88780
MX   88780
Manufacturer Contact
jason fiest
one invacare way
elyria, OH 44035
8003336900
MDR Report Key8116654
MDR Text Key128791080
Report Number9616091-2018-00017
Device Sequence Number1
Product Code IOR
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberNA:MYON
Device Catalogue NumberMYON
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/29/2018
Initial Date FDA Received11/29/2018
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) Required Intervention;
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