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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN NON REMOVABLE FOOT/LEGREST 9153645345; FOOTREST, WHEELCHAIR

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UNKNOWN NON REMOVABLE FOOT/LEGREST 9153645345; FOOTREST, WHEELCHAIR Back to Search Results
Model Number T93HA
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
The right side of the t93ha were broken at a weld, and will not hook on to the chair.
 
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Brand Name
NON REMOVABLE FOOT/LEGREST 9153645345
Type of Device
FOOTREST, WHEELCHAIR
Manufacturer (Section D)
UNKNOWN
OH
Manufacturer (Section G)
UNKNOWN
OH
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44036
8003336900
MDR Report Key4374996
MDR Text Key21833228
Report Number1525712-2014-09025
Device Sequence Number1
Product Code KNO
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
Report Date 12/09/2014
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 NumberT93HA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/09/2014
Initial Date FDA Received12/31/2014
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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