BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHILD'S FACE MASK WITH SO SOFT* EARLOOPS (DISNEY)

    MDR report key: 17345228 · Received July 18, 2023

    Report

    Report Number
    9616096-2023-00080
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    July 10, 2023
    Report Date
    September 13, 2023
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    OXZ
    UDI-DI
    30680651328565
    PMA / PMN Number
    K113340
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS COMPLAINT WAS NOT RETURNED. LACK OF SAMPLES AND LOT NUMBER MAKE IT DIFFICULT TO DETERMINE THE ROOT CAUSE. SINCE VISUAL AND FUNCTIONAL INSPECTIONS CANNOT BE PERFORMED, WE CANNOT CONFIRM OR REPLICATE THE INCIDENT REPORTED. COMPLAINT TREND WAS REVIEWED FOR CODE 32856 AND FAILURE MODE "REACTION" FOR THE PAST 12 MONTHS FROM (B)(6) 2022 TO (B)(6) 2023. THERE IS NO UPWARD TREND FOR THE PAST 12 MONTHS. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS COMPLAINT WAS NOT RETURNED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    CUSTOMER LAST WORKED (B)(6) 2023 AND GOT ON DISABILITY BECAUSE SHE IS UNABLE TO WEAR MASKS PROVIDED AT HER PLACE OF WORK. CUSTOMER STATES THERE WAS REDNESS AND IRRITATION TO FACE, UNDER EYE TO NECK. A PATCH TEST WAS PERFORMED. CUSTOMER WAS PRESCRIBED ANTIHISTAMINES, PREDNISONE, AND AN EPIPEN FOR USE IN AN ALLERGIC EMERGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142116 CHILD'S FACE MASK WITH SO SOFT* EARLOOPS (DISNEY) ICP FACIAL PROTECTION OXZ O&M HALYARD, INC. 32856 UNKNOWN 30680651328565

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other