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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE TAYLOR STREET TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL
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INVACARE TAYLOR STREET TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL Back to Search Results
Model Number MYON
Device Problems Break (1069); Entrapment of Device (1212); Device Tipped Over (2589)
Patient Problem Fall (1848)
Event Date 02/01/2015
Event Type  malfunction  
Manufacturer Narrative
Right hand side castor wheel become trapped between a dropped curb and the road.Castor then broke as wheelchair was forced forward, causing user to tip out of the chair.The action 3 is the same /similar to the myon which is manufactured and/or marketed by invacare in the u.S.This alleged incident occurred in (b)(6).
 
Event Description
Right hand side castor wheel become trapped between a dropped curb and the road.Castor then broke as wheelchair was forced forward, causing user to tip out of the chair.The action 3 is the same /similar to the myon which is manufactured and/or marketed by invacare in the u.S.This alleged incident occurred in (b)(6).
 
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Brand Name
TRANSPORT 20 IN X 16 IN 9153637574
Type of Device
WHEELCHAIR, MECHANICAL
Manufacturer (Section D)
INVACARE TAYLOR STREET
1200 taylor street
elyria OH 44036
Manufacturer (Section G)
INVACARE TAYLOR STREET
1200 taylor street
elyria OH 44036
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5090956
MDR Text Key26531237
Report Number1525712-2015-04597
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 company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Report Date 09/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMYON
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/21/2015
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
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