BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE HANDS FREE

    MDR report key: 2896540 · Received December 31, 2012

    Report

    Report Number
    1419937-2012-00844
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    October 15, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE CUSTOMER'S INCLUDING A FINAL ATTEMPT BY LETTER, TO GET ADDITIONAL COMPLAINT INFORMATION, INCLUDING MEDICAL TREATMENT, IF ANY, WERE UNSUCCESSFUL. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO (B)(4) THAT SHE HAD AN ALLERGIC REACTION TO HER BREAST PUMP AND HAD TO HAVE SURGERY AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE HANDS FREE HGX MEDELA AG 67060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other