BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 22803644 · Received August 14, 2025

    Report

    Report Number
    1043572-2025-00077
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 17, 2025
    Report Date
    August 14, 2025
    Manufacturer
    STERIS CORPORATION
    Product Code
    LWG
    UDI-DI
    00724995163822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW-UP WITH USER FACILITY PERSONNEL AND A STERIS ACCOUNT MANAGER IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED EVENT WAS DUE TO INCOMPATIBLE CLEANING AGENTS BEING USED ON THE TABLE PADS. USER FACILITY PERSONNEL WERE UTILIZING AN OXYCIDE DAILY DISINFECTANT CLEANER THAT CONSISTS OF HYDROGEN PEROXIDE AND PERACETIC ACID. THE CLEANING INSTRUCTIONS FOR THE MATTRESS PADS AND STERIS SURGICAL TABLE OPERATOR MANUALS STATES, "CAUTION - POSSIBLE EQUIPMENT DAMAGE: THE USE OF H2O2 + PAA (HYDROGEN PEROXIDE + PERACETIC ACID) IS STRONGLY DISCOURAGED FOR USE ON ALL STERIS PRODUCTS." USER FACILITY PERSONNEL WERE COUNSELED ON THE IMPORTANCE OF USING PROPER CLEANING AGENTS FOR THEIR TABLE PADS AND SURGICAL TABLES. STERIS EVALUATED THE REPORTED EVENT AND DETERMINED IT DOES NOT MEET OUR REPORTING CRITERIA UNDER 21 CFR PART 803. IT SHOULD BE NOTED THAT STERIS IS SUBMITTING A MEDICAL DEVICE REPORT (MDR) SOLELY DUE TO THE RECEIPT OF THE USER FACILITY MEDWATCH REPORT WHICH IS IN ACCORDANCE WITH OUR PROCEDURES AND POLICIES. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED VIA MEDWATCH (B)(4) THAT THEIR "MATTRESSES COMING APART AT SEAMS". NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557255 NA TABLE PAD LWG STERIS CORPORATION TABLE PAD 00724995163822

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown