BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 4213159 · Received September 12, 2014

    Report

    Report Number
    3009974348-2014-00025
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AMEDA RECEIVED THE RETURNED A/C ADAPTER CORD FOR INVESTIGATION ON 08/15/2014. RESULT OF THE INVESTIGATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A REP FOR (B)(6) CONTACTED AMEDA. SHE STATED THE CUSTOMER COMPLAINED THAT AN A/C ADAPTER "CORD BLEW UP DURING USE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566677 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1