BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIKING SELF SEAL POUCHES

    MDR report key: 24058486 · Received January 13, 2026

    Report

    Report Number
    MW5182177
    Event Type
    Other
    Date Received
    January 13, 2026
    Manufacturer
    HEALTHMARK INDUSTRIES CO., INC.
    Product Code
    FRG
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ALL OTHER STEAM POUCHES ON THE MARKET ARE LABELED THAT LUMENS CAN OR CANNOT BE STERILIZED IN STERILE PROCESSING DEPT. HOSPITALS AND AMBULATORY SURG CENTERS. NOT THIS ONE, WHEN ASKED REP/EDUCATOR STATED SURE YOU CAN, WHERE DOES IT SAY THAT? RESPONSE WAS ONLY IT DOESN'T SAY YOU ¿CAN¿T¿, OTHER COMPANIES SAY NO LUMENS BECAUSE THEY DID NOT TEST FOR LUMENS. WHY CAN THIS COMPANY BE WISHY-WASHY ABOUT SOMETHING CAN AFFECT PATIENTS IF THINGS ARE NOT STERILE? PLEASE ASSIST THEY (HEALTH MARK) NEEDS TO SAY ONE WAY OR THE OTHER- THANK YOU. PRODUCT IS ATTACHED FOR YOUR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124323 STERIKING SELF SEAL POUCHES WRAP, STERILIZATION FRG HEALTHMARK INDUSTRIES CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown