BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIERPRO

    MDR report key: 17806928 · Received September 25, 2023

    Report

    Report Number
    17806928
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    June 8, 2023
    Report Date
    June 26, 2023
    Manufacturer
    SVS LLC
    Product Code
    KKX
    UDI-DI
    00818566010193
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN OPENING A PACK OF STERILE SINGLE USE TOWELS, DEBRIS OF UNKNOWN ORIGIN, SIMILAR TO HAIR, WAS FOUND IN THE WEAVE OF THE TOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561821 PREMIERPRO DRAPE, SURGICAL KKX SVS LLC 8326B CBBL09-04 00818566010193

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown