BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 6300269 · Received February 3, 2017

    Report

    Report Number
    3009974348-2017-00246
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    January 4, 2017
    Report Date
    January 5, 2017
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS CONTACTED BY PHONE AND EMAIL MULTIPLE TIMES IN THE PAST MONTH REQUESTING RETURN OF THE DAMAGED AMEDA CAR ADAPTER FOR INVESTIGATION. AS OF THIS DATE, CUSTOMER HAS NOT RETURNED THE PRODUCT SO NO VISUAL INSPECTION OR TESTING WAS COMPLETED. IF PRODUCT IS RETURNED TO AMEDA, INC., A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2017 TO REPORT AN INCIDENT THAT OCCURRED THE DAY BEFORE WHEN SHE INSERTED THE AMEDA CAR ADAPTER INTO HER CAR'S 12 V RECEPTACLE TO PUMP IN THE CAR. THE CUSTOMER REPORTS A SUDDEN SPARK WAS EMITTED FROM THE ADAPTER FRIGHTENING HER BUT SHE STATES NO INJURY OCCURRED. SHE STATES THE CAR ADAPTER FELL APART WHEN SHE REMOVED IT FROM THE CAR RECEPTACLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84869 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24501649

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR