BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE

    MDR report key: 336232 · Received June 4, 2001

    Report

    Report Number
    MW4003000
    Event Type
    Malfunction
    Date Received
    June 4, 2001
    Date of Event
    March 9, 2001
    Report Date
    April 25, 2001
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PURCHASED A USED BREAST PUMP AT A CONSIGNMENT STORE. THE MFR'S INSERTS INCLUDED A WARNING THAT THIS IS A SINGLE USE DEVICE THAT SHOULD NOT BE SOLD FOR REUSE. THE INSERT STATED THAT AN INTERNAL DIAPHRAM COULD NOT BE EFFECTIVELY STERILIZED. THE CONSUMER WAS CONCERNED THAT THE STORE WAS STILL SELLING THESE USED SINGLE USE DEVICES.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 7/3/01: WHICH MODEL THE CONSUMER PURCHASED CANNOT BE DETERMINED FROM THE REPORT. MEDELA STRONGLY EMPHASIZES THAT THE PUMP IN STYLE IS A SINGLE USER PRODUCT. UNFORTUNATELY MEDELA INC CAN'T DO MORE THAN WARN, TO PREVENT THE PRODUCT FROM BEING REUSED AND RESOLD. A CONSIGNMENT STORE RESELLING A USED SINGLE USER PRODUCT IS VIOLATING THE INTENDED USE OF THE PRODUCT. MEDELA INC HAS NO KNOWLEDGE OF THE CURRENT STATUS OF THE DEVICE, WHETHER IT HAS BEEN RETURNED TO THE CONSIGNMENT STORE OR HAS REMAINED WITH THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25745 PUMP IN STYLE ELECTRIC BREAST PUMP HGX MEDELA, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA