BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVACARE SOLACE 42" BARRIATRIC MATTRESS

    MDR report key: 2705407 · Received August 9, 2012

    Report

    Report Number
    3007008421-2012-00002
    Event Type
    Other
    Date Received
    August 9, 2012
    Date of Event
    June 1, 2012
    Report Date
    August 9, 2012
    Manufacturer
    FOAM CRAFT A DIV OF FUTURE FOAM INC.
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORTED INCIDENT RELATES TO THE MATTRESS COVER COMING OFF THE MATTRESS AND THE CONSUMER GOT A STAPLE IN HIS TOE. THE MANUFACTURER OF THE MATTRESS DOES NOT, AT ANY TIME, USE STAPLES ON ANY OF THEIR PRODUCTS; PHONE CALLS AND EMAILS HAVE BEEN MADE TO THE COMPLAINANT FOR RESOLUTION OF THE PROBLEM. FOLLOWING IS A LIST OF DATES AND ATTEMPTS THAT WERE MADE TO REACH THE COMPLAINING PARTY TO NO AVAIL: (B)(6), 2012 (12:10PM) VIA PHONE LEFT MESSAGE - NO ANSWER. (B)(6), 2012 (12:20PM) VIA EMAIL SENT CONTACT INFORMATION - NO ANSWER. (B)(6), 2012 (11:50AM) VIA PHONE LEFT MESSAGE WITH RECEPTIONIST ((B)(6)) - NO CALL BACK AND NO ANSWER. (B)(6), 2012 (9:29AM) SENT ANOTHER EMAIL, LEFT CONTACT INFORMATION - NO ANSWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE SOLACE 42" BARRIATRIC MATTRESS BARMATT42 MATTRESS IKY FOAM CRAFT A DIV OF FUTURE FOAM INC. BARMATT42

    Patients

    Seq Age Sex Outcome Treatment
    1