BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCEDURE MASK YELLOW

    MDR report key: 17241667 · Received June 30, 2023

    Report

    Report Number
    9616096-2023-00071
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 3, 2021
    Report Date
    August 15, 2023
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXX
    UDI-DI
    30680651471179
    PMA / PMN Number
    K831148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. 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, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    NO SAMPLE WAS PROVIDED FOR EVALUATION. INVESTIGATION OF REPORT WAS LIMITED DUE TO LACK OF SAMPLE OR LOT NUMBER. A ROOT CAUSE WAS NOT IDENTIFIED. COMPLAINT TREND WAS REVIEWED FOR CODE 47117. FAILURE MODE (COMES APART/COMES OFF) FOR THE PAST 12 MONTHS FROM MAY 2022 TO MAY 2023 DOES NOT SHOW AN UPWARD TREND. NOTIFICATION WAS SENT TO MANUFACTURING LEADERS FOR AWARENESS. 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, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    LOOP FROM MASK TORE WHILE APPLYING FIRST TIME. THERE WERE 3 MASKS FROM THE BOX THAT THE SAME THING HAPPENED. 1 LOOP TORE OFF MASK ON FIRST APPLICATION. MASK WAS IN USE FOR COVID PANDEMIC PPE REQUIREMENT. THIS COMPLAINT WAS DISCOVERED DURING COMPLETION OF GLOBAL POST MARKET SURVEILLANCE REPORT MAUDE SEARCH PERFORMED ON JUNE 9TH, 2023. THE MAUDE REFERENCE NUMBER IS (B)(4). THE SITE WAS UNABLE TO LOCATE A DIRECT COMPLAINT RECEIVED FOR THIS ISSUE/INCIDENT FROM THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344732 PROCEDURE MASK YELLOW ICP FACIAL PROTECTION FXX O&M HALYARD, INC. 47117 UNKNOWN 30680651471179

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown