BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYMPHONY W/BREASTSHIELD

    MDR report key: 1880506 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00012
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    April 10, 2010
    Report Date
    April 10, 2010
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K020518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REPRESENTATIVE SPOKE WITH THE CUSTOMER. CUSTOMER CONFIRMED THE PUMP WAS OFF WHEN SHE REMOVED THE BREASTSHIELD, HER NIPPLE HAD NOT BEEN RUBBING ON THE INSIDE OF THE TUNNEL, AND THE AREOLA HAD NOT BEEN RUBBING OR PULLED INSIDE THE TUNNEL. ADDITIONAL ATTEMPTS TO OBTAIN INFORMATION WERE MADE (TWICE ON (B)(6) 2010, ONCE (B)(6) 2010 AND ONCE ON (B)(6) 2010), BUT NO INFORMATION WAS PROVIDED (CUSTOMER WAS NOT AVAILABLE AND DID NOT RETURN CALLS). NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED AT THAT TIME. 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 STATED SHE RECEIVED A BLISTER FROM USING THE SOFTFIT BREASTSHIELD WITH THE SYMPHONY PUMP. WHEN SHE REMOVED THE BREASTSHIELD, A PORTION OF HER SKIN WAS TORN OFF. THE CUSTOMER STATED SHE WAS IN PAIN AND WOULD GO TO THE DOCTOR ON MONDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY W/BREASTSHIELD PUMP, BREAST, POWERED HGX MEDELA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other