BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACE TENT

    MDR report key: 2805540 · Received November 19, 2010

    Report

    Report Number
    9680866-2010-00005
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    UNOMEDICAL S.A. DE C.V.
    Product Code
    BYG
    PMA / PMN Number
    K781055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON RESULTS OF THE INVESTIGATION PERFORMED BY QUALITY CONTROL DEPT, THE COMPLAINT WAS CONFIRMED. THE SURFACE OF THE MASKS TURNED STICKY DUE TO MIGRATION OF SOME MATERIALS IN THE PVC COMPOUND, (B)(4), USED IN THE MFG OF OXYGEN MASKS. THE (B)(4) MIGRATED TO THE MASK SURFACE MAKING IT STICKY. ACCORDING TO (B)(4), DATED (B)(4) 2010, COMPOUND (B)(4) WAS TESTED, AND IT MET ISO 10993 REQUIREMENTS FOR CYTOTOXICITY. THE INVESTIGATION CONFIRMED THAT A TOTAL OF (B)(4) BATCHES OF PVC COMPOUND FROM (B)(4) 2009 THROUGH (B)(4) 2010 HAD A SIMILAR REACTION (MIGRATION OF COMPONENTS). THESE BATCHES OF PVC WERE USED IN THE MFG OF SEVERAL OXYGEN MASK PRODUCTS ALREADY IN THE MARKET, WHICH WERE PRODUCED FROM (B)(4) 2010. A (B)(4) HISTORICAL REVIEW OF COMPLAINTS REVEALED NO SIMILAR REPORTED COMPLAINTS OR ADVERSE EVENTS DUE TO STICKY MASKS ON THE (B)(4).

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS. THE SURFACE OF OXYGEN MASK WAS STICKY. IT WAS DETECTED DURING 100% VISUAL INSPECTION, AND THE PROBLEM AFFECTED (B)(4) PIECES OF SMITHS MEDICAL PRODUCT 001490, LOT# 10-11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FACE TENT MASK, OXYGEN BYG UNOMEDICAL S.A. DE C.V. 001490 10-11

    Patients

    Seq Age Sex Outcome Treatment
    1