BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TDX SP2

    MDR report key: 8732235 · Received June 25, 2019

    Report

    Report Number
    1525712-2019-00016
    Event Type
    Injury
    Date Received
    June 25, 2019
    Report Date
    May 28, 2019
    Manufacturer
    INVACARE TAYLOR ST.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGED ARM PADS WERE REQUESTED TO BE RETURNED, HOWEVER THEY HAD ALREADY BEEN DISPOSED OF BY THE END USER. THERE WERE NO PICTURES AVAILABLE OF THE ARM PADS. THE PROVIDER HAS REPLACED THE PADS WITH A DIFFERENT STYLE. THIS RECORD IS BEING FILED IN AN ABUNDANCE OF CAUTION DUE TO THE ALLEGED INJURY AND MEDICAL TREATMENT RECEIVED. THE OWNER¿S MANUAL FOR THIS DEVICE INCLUDES THE FOLLOWING WARNINGS: RISK OF DEATH, INJURY OR DAMAGE. CONTINUED USE OF THE PRODUCT WITH DAMAGED PARTS COULD LEAD TO THE PRODUCT MALFUNCTIONING, CAUSING INJURY TO THE USER AND/OR CAREGIVER. SHARP EDGES CAN CAUSE SERIOUS INJURY. BE MINDFUL THAT SOME PARTS MAY HAVE SHARP EDGES. USE CAUTION WHEN ENCOUNTERING THESE SHARP EDGES.

    Description of Event or Problem · 1

    IT IS ALLEGED THE LEFT AND RIGHT ARM PADS ON THE WHEELCHAIR HAVE BROKEN. THE PLASTIC AROUND THE SIDES CRACKED AND BECAME VERY SHARP, THE END USERS¿ ELBOW WAS SCRATCHED. THE END USER SOUGHT MEDICAL ATTENTION FOR A SORE ON HIS ELBOW WHICH BECAME INFECTED AND HAD TO BE DRAINED. HE DOESN'T KNOW IF THE SORE THAT WAS INFECTED WAS CAUSED BY THE CUTS FROM THE ARM PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524117 TDX SP2 POWERED WHEELCHAIR ITI INVACARE TAYLOR ST. NA:TDXSP2-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention