BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKLAR®

    MDR report key: 21804614 · Received April 9, 2025

    Report

    Report Number
    21804614
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    April 3, 2025
    Report Date
    April 4, 2025
    Manufacturer
    SKLAR CORPORATION
    Product Code
    FFO
    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

    BRAND NEW SURGICAL INSTRUMENTS, PURCHASED AND UNPACKAGED, INSPECTED PRIOR TO PROCESSING THROUGH THE SPD [STERILE PROCESSING DEPARTMENT] DEPARTMENT, PITTING NOTED ON 2 OF THE 20 ITEMS PURCHASED; INSTRUMENT NOTED WITH PITTING IS A NORFOLK-NORWICH RETRACTOR FROM SKLAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454180 SKLAR® RETRACTOR, SELF-RETAINING FFO SKLAR CORPORATION 42-1631

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown