BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP IN STYLE ADVANCED, BACK PACK

    MDR report key: 2020313 · Received March 11, 2011

    Report

    Report Number
    1419937-2011-00011
    Event Type
    Other
    Date Received
    March 11, 2011
    Date of Event
    May 18, 2010
    Report Date
    May 18, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL PUMP WAS RETURNED FOR EVAL. THE NOTES ONLY STATE "PC BOARD," WHICH COULD BE TAKEN TO MEAN AN ISSUE WAS FOUND WITH THE PC BOARD, BUT THIS IS NOT EXPLICITLY STATED. THE DEVICE HAS SINCE BEEN SCRAPPED; THEREFORE, NO CONCLUSION CAN BE DRAWN. AS PART OF COMPLAINT REMEDIATION ACTIVITIES, HISTORICAL COMPLAINT RECORDS ARE BEING REVIEWED FOR POSSIBLE ADVERSE EVENTS. MEDELA IS COMMITTED TO CREATING AN EFFECTIVE COMPLAINT HANDLING PROCESS TO ASSURE COMPLAINTS ARE PROCESSED IN A TIMELY MANNER AND EVALUATED FOR PART 803 REPORTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PUMP SHE HAD BEEN USING WAS TOO STRONG ON THE LOW SETTING, CAUSING SO MUCH PAIN AND RIPPING OF THE SKIN, SHE WENT TO THE HOSPITAL WITH THE PUMP AND MET HER DOCTOR. THE CUSTOMER'S DOCTOR DID NOT HAVE A GAUGE WITH WHICH TO TEST THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCED, BACK PACK PUMP, BREAST, POWERED HGX MEDELA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other