BEUDAMED
    FDA Adverse Event Summary report: N

    OR STERILE TOWEL

    MDR report key: 8439290 · Received March 21, 2019

    Report

    Report Number
    8439290
    Date Received
    March 21, 2019
    Date of Event
    March 1, 2019
    Report Date
    March 13, 2019
    Manufacturer
    ALLCARE, INC.
    Product Code
    LYU
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THERE WAS EXCESSIVE LINT COMING OFF OF THE STERILE TOWELS. THE SURGICAL SITE HAD TO BE WASHED OFF AND RE-PREPPED. THIS HAS BEEN INVESTIGATED BY OUR INFECTION PREVENTION TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232125 OR STERILE TOWEL ACCESSORY, SURGICAL APPAREL LYU ALLCARE, INC. 11RI14

    Patients

    Seq Age Sex Outcome Treatment
    1