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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE TAYLOR STREET TDXSP WET BLACK EURO NARROW BASE W/ 18-1 SSD GEAR BOX; WHEELCHAIR, POWERED

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INVACARE TAYLOR STREET TDXSP WET BLACK EURO NARROW BASE W/ 18-1 SSD GEAR BOX; WHEELCHAIR, POWERED Back to Search Results
Model Number TDXSI-HD
Device Problems Unintended Collision (1429); Mechanics Altered (2984)
Patient Problems Bruise/Contusion (1754); Fall (1848)
Event Date 02/19/2014
Event Type  malfunction  
Manufacturer Narrative
Mdr is being submitted as a result of a retrospective complaint review.
 
Event Description
Consumer states that the chair accelerated, turned circles, and threw her into some wooden boxes in the aisle.The chair then threw her into shelving which bruised her leg and her hand.
 
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Brand Name
TDXSP WET BLACK EURO NARROW BASE W/ 18-1 SSD GEAR BOX
Type of Device
WHEELCHAIR, POWERED
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 Key5758088
MDR Text Key49160651
Report Number1525712-2016-02173
Device Sequence Number1
Product Code ITI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 05/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberTDXSI-HD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/05/2014
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 Weight121
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