BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDELA SYMPHONY BREAST PUMP-HOSPITAL GRADE

    MDR report key: 20452578 · Received October 11, 2024

    Report

    Report Number
    MW5161026
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    September 30, 2024
    Report Date
    October 8, 2024
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    NICU MOM WAS USING THE HOSPITAL GRADE SYMPHONY PUMP. SHE SCREAMED AND PULLED THE PUMP AWAY FROM HER RIGHT BREAST. SHE STATED THAT THE PUMP JUMPED TO A HIGHER SUCTION AND "RIPPED" HER NIPPLE. NICU LACTATION CONSULTANT (LC) WAS PRESENT AND EXCHANGED PUMP FOR A DIFFERENT ONE FROM MNB. LC TESTED THE PUMP AGAINST HER OWN SKIN AND STATED THAT IT IS MORE INTENSE THAN IT SHOULD BE, AGAIN ON THE INITIATION MODE AT THE LOWER SETTING. I WENT BACK IN TO ASSIST WITH ANOTHER PUMP SESSION AND MOM WAS TEARFUL STATING THAT HER NIPPLE WAS STILL PAINFUL AND SHE WAS NOT ABLE TO PUMP. I WORKED WITH HER HAND EXPRESSING EACH BREAST ALLOWING HER TO REST AND HEAL HER BREAST FOR THE NEXT SEVERAL SESSIONS, RESUMING PUMPING THE NEXT DAY IN NECESSARY. I BROUGHT THE PUMP TO OUR LC OFFICE AND OBSERVED A SESSION. THE SUCTION FELT TYPICAL TO ME BUT AROUND 4 MIN IT SHUT OF WITH A SYSTEM ERROR DISPLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353120 MEDELA SYMPHONY BREAST PUMP-HOSPITAL GRADE PUMP, BREAST, POWERED HGX MEDELA AG 0240108

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other BREAST PUMP| COMMONLY KNOWN AS: ADVIL/MOTRIN, TAKE 1 TABLET (800 MG) BY MOUTH EVERY 8 (EIGHT) HOURS IF NEEDED FOR MODERATE PAIN MILD PAIN, FEVER OR HEADACHES. | COMMONLY KNOWN AS: PERCOCET, TAKE 1 TABLET BY MOUTH EVERY 6 (SIX) HOURS IF NEEDED FOR MODERATE PAIN OR SEVERE PAIN FOR UP TO 3 DAYS. | IBUPROFEN 800 MG TABLET| OXYCODONE-ACETAMINOPHEN 5-325 MG TABLET| PHENERGAN, TAKE 1 TABLET (12.5 MG) BY MOUTH EVERY 6 (SIX) HOURS IF NEEDED FOR NAUSEA OR VOMITING FOR UP TO 3 DAYS. | PROMETHAZINE 12.5 MG TABLET