BEUDAMED
    FDA Adverse Event Other Summary report: N

    TIARA

    MDR report key: 975255 · Received January 4, 2008

    Report

    Report Number
    2050001-2007-00001
    Event Type
    Other
    Date Received
    January 4, 2008
    Date of Event
    May 7, 2007
    Report Date
    January 4, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST WAS SENT VIA E-MAIL TO CARDINAL HEALTH CUSTOMER SERVICE REP ASKING THEM TO CONTACT THE DISTRIBUTOR IN ORDER TO OBTAIN ADDITIONAL INFORMATION AND RETURN OF THE DEVICE FOR EVALUATION. THEY WERE INFORMED BY THE DISTRIBUTOR THAT THE END USER HAD DISCARDED THE DEVICE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION CONCERNING THE EVENT AND THE CONDITION OF THE PATIENT/END USER WAS DOCUMENTED BY A CARDINAL HEALTH CUSTOMER SERVICE REP IN RESPONSE TO A PHONE CONVERSATION WITH THE DISTRIBUTOR'S REPRESENTATIVE. "PATIENT USING TMS-09 ADJ (NEOPRENE). FACE SWELLED UP AND DEVELOPED SORES THAT WERE SEEPING. PATIENT WENT TO HER LOCAL CARE CENTER AND THEY DETERMINED THAT SHE IS ALLERGIC TO NEOPRENE. PATIENT STOPPED USING PRODUCT. REPLACING WITH TMS-11 [POLY/COTTON/LYCRA BLEND]."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIARA CPAP HEADGEAR/CHIN STRAPS BZD CARDINAL HEALTH 207, INC. TOPAZ ADJUSTABLE CHIN STRAP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other