BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIMOM OPERA

    MDR report key: 22568490 · Received July 22, 2025

    Report

    Report Number
    MW5173053
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    July 10, 2025
    Report Date
    July 18, 2025
    Manufacturer
    UNIMOM CO
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BREAST PUMP LOST SUCTION AFTER 8 MONTHS OF USE AND MAKES A CLUNKING NOISE WHEN USED. THE RIGHT SIDE OF THE PUMP HAS LESS SUCTION THAN THE LEFT SIDE. NOT FIXED BY SWAPPING PUMP TUBING OR FLANGE SETUP. CONTACTED THE MANUFACTURER ABOUT THE ISSUE AND WAS SENT A NEW LOANER PUMP. RIGHT OUT OF THE BOX THE NEW LOANER PUMP HAD NO SUCTION ON THE RIGHT SIDE AT ALL. LEFT SIDE WORKED OK. SWITCHED TUBING AND FLANGE SETUPS AND THE SET THAT DIDN'T WORK WHEN CONNECTED TO THE RIGHT SIDE WORKS WHEN CONNECTED TO THE LEFT, SO THE ISSUE IS THE PUMP. LOSING BREAST MILK SUPPLY BECAUSE OF THIS ISSUE. HAVE VIDEOS OF THE PUMPS AVAILABLE IF NEEDED. PATIENT:4829. DEVICE:1146; 4039. REFERENCE REPORT: MW5173054.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2725991 UNIMOM OPERA PUMP, BREAST, POWERED HGX UNIMOM CO OPERA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other FISH OIL.| MIRALAX.| MULTIVITAMIN.| TOPICAL AZALEAS ACID GEL.