BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER LABORATORIES INC GEL WARMER

    MDR report key: 14711608 · Received June 16, 2022

    Report

    Report Number
    MW5110341
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    June 9, 2022
    Report Date
    June 13, 2022
    Manufacturer
    PARKER LABORATORIES, INC.
    Product Code
    MUI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ULTRASOUND GEL BOTTLE EXPLODED AND HOT GEL FELL ON THE EMPLOYEE'S HAND AND THE PATIENT'S BREAST. SHE REPORTED RED SKIN, BUT NO BLISTERING. I ASSESSED THE PATIENT'S SKIN. SKIN IS FULLY INTACT. SLIGHT REDNESS NOTED BETWEEN THE BREASTS. I GAVE HER AN ICE PACK TO USE THROUGHOUT THE DAY AND RECOMMENDED THAT SHE PICK UP SOME BACITRACIN CREAM. I TOLD HER THAT SHE CAN TAKE TYLENOL OR IBUPROFEN EVERY 6 HOURS AS NEEDED IF SHE NOTES ANY SORENESS OR PAIN. GEL WARMER WAS NOTED TO BE SET ON HIGH BUT OUT OF RANGE AT 141 DEGREES F. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120441 PARKER LABORATORIES INC GEL WARMER MEDIA, COUPLING, ULTRASOUND MUI PARKER LABORATORIES, INC. 8203
    2120442 ULTRASOUND GEL LUBRICANT, PATIENT MUI PARKER LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female