BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTI-FOG SURGICAL MASK, GREEN WITH FILM STRIP

    MDR report key: 8787301 · Received July 12, 2019

    Report

    Report Number
    9616096-2019-00004
    Event Type
    Injury
    Date Received
    July 12, 2019
    Report Date
    March 14, 2019
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXX
    UDI-DI
    30680651492358
    PMA / PMN Number
    K823078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO O&M HALYARD, INC. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS

    Description of Event or Problem · 1

    DURING A RETROSPECTIVE REVIEW WITH THE FDA ESG HELP DESK IT WAS DETERMINED THAT THIS COMPLAINT WAS SENT TO THE TEST REGION AND NOT THE FDA PRODUCTION REGION; THEREFORE, THIS COMPLAINT IS BEING SUBMITTED TO THE PRODUCTION REGION ON (B)(6) 2019. IT WAS ALLEGE BY A DOCTOR THAT THE ANTI-FOG GREEN SURGICAL MASKS ARE PRONE TO CONDENSATION AND DROPS INTO THE SURGICAL SITE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579403 ANTI-FOG SURGICAL MASK, GREEN WITH FILM STRIP ICP FACIAL PROTECTION PRODUCTS FXX O&M HALYARD, INC. 49235 UNKNOWN 30680651492358

    Patients

    Seq Age Sex Outcome Treatment
    1 Other