BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE LITE ONE* SURGICAL MASK, BLUE

    MDR report key: 16701812 · Received April 7, 2023

    Report

    Report Number
    9616096-2023-00001
    Event Type
    Injury
    Date Received
    April 7, 2023
    Report Date
    May 25, 2023
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXX
    UDI-DI
    30680651481000
    PMA / PMN Number
    K823078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLES WERE EVALUATED UNDER AMBIENT LIGHT CONDITIONS. THE MASK WAS FOUND TO BE ASSEMBLED ACCORDING TO THE SPECIFICATION DRAWING FOR LOT NUMBER AM0343431. EACH MASK WAS OPENED FULLY AND INSPECTED ON THE INSIDE AND THE OUTSIDE. THERE ARE NO DEFECTS OBSERVED ON ANY OF THE SAMPLES. THE FAILURE ANALYSIS LAB WAS NOT ABLE TO EVALUATE OR CONFIRM THE ROOT CAUSE FOR THE REACTION EXPERIENCED BY THE CUSTOMER. A DEVICE HISTORY RECORDS (DHR) EVALUATION WAS PERFORMED FOR THE CODE 48100 IDENTIFIED IN THE COMPLAINT. ACCORDING TO THE DOCUMENTED RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES AND SPECIFICATIONS. THE PRODUCT WAS RELEASED BY QUALITY ASSURANCE. A QUALITY NONCONFORMANCE WAS NOT REPORTED DURING PRODUCTION. MANUFACTURING CONDUCTS VISUAL AND FUNCTIONAL INSPECTIONS OF EACH DEVICE THROUGHOUT PRODUCTION ASIDE FROM THE QA INSPECTION. NOTIFICATION WAS SENT TO MANUFACTURING LEADERS FOR AWARENESS. THERE WAS NO COMPLAINT TREND FOR THE CODE 48100. 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 21 CFR 803, AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT REPORTED IS AVAILABLE FOR EVALUATION. WE ARE AWAITING RECEIPT OF SAMPLE FROM THE REPORTER. UPON CONCLUSIONS OF THE COMPLAINT INVESTIGATION A FOLLOW UP REPORT WILL BE SUBMITTED. 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 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

    THE CUSTOMER REPORTED THAT A FEW EMPLOYEES WERE HAVING ALLERGIC REACTIONS THAT CAUSED WOUNDS ON THE FACE WHILE WEARING THE MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795916 THE LITE ONE* SURGICAL MASK, BLUE ICP FACIAL PROTECTION PRODUCTS FXX O&M HALYARD, INC. 48100 AM0343431 30680651481000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other