BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WISP MASK, FABRIC FRAME

    MDR report key: 3890868 · Received June 4, 2014

    Report

    Report Number
    2518422-2014-00848
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K121631
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUCTIONS FOR USE FOR THIS MASK STATES TO "INSPECT THE MASK AND REPLACE IT IF THE CUSHION HAS HARDENED OR IS TORN, OR IF ANY PARTS ARE BROKEN." THE END USER WAS INSTRUCTED BY A CLINICIAN AT THE DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER TO REPLACE HER MASK EVERY 6 MONTHS. THE END USER USED THIS MASK FOR GREATER THAN 9 MONTHS. BASED ON THE INFO AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    AN END USER ALLEGED THE FABRIC OF THE WISP MASK HEADGEAR TORE, EXPOSING THE PLASTIC FRAME, AND RESULTED IN A CUT ON HER EAR THAT REQUIRED STITCHES. THE END USER DID NOT EXPERIENCE PERMANENT INJURY. THE MASK WAS DISCARDED BY THE END USER AND IS NOT AVAILABLE FOR EVAL BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326929 WISP MASK, FABRIC FRAME VENTILATOR, NON-CONTINUOUS RESPIRATOR BZD RESPIRONICS INC. 1094051

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other