BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY BREAST PUMP

    MDR report key: 2963430 · Received February 13, 2013

    Report

    Report Number
    1419937-2013-00096
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MEDELA A G
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED VIA EMAIL THAT SHE HAS HAD A SERIOUS ALLERGIC REACTION WHILE USING THE SYMPHONY PUMP. HER DOCTOR THINKS SHE MAY BE HAVING AN ALLERGIC REACTION TO LATEX. SHE SOLELY BREAST FEEDS WITH THE PUMP. ATTEMPTS TO REACH THE CUSTOMER WERE UNSUCCESSFUL. THE CUSTOMER ONLY PROVIDED AN E MAIL ADDRESS. SHE HAS NOT RESPONDED TO ANY ATTEMPTS MADE BY THE COMPLAINT DEPARTMENT OR THE CLINICIAN. NOR DID SHE CALL IN AS REQUESTED BY CUSTOMER SERVICE. CUSTOMER SERVICE DID INFORM THE CUSTOMER VIA E MAIL THAT OUR PUMPS AND PRODUCTS DO NOT CONTAIN LATEX. A MEDELA CLINICIAN SENT AN E MAIL TO THE CUSTOMER WITH ANSWERS TO THE QUESTION REGARDING LATEX. THE CLINICIAN INFORMED THE CUSTOMER THAT THERE IS NO LATEX IN MEDELA PRODUCTS. SHE ALSO GAVE THE CUSTOMER INFORMATION REGARDING USE OF A SKIN BARRIER TO PREVENT SKIN CONTACT WITH THE PUMP'S BREAST SHIELD AND ALSO PROVIDED INFORMATION REGARDING HYPO-ALLERGIC DISH SOAP TO TRY. THE ISSUE IS RESOLVED WITH THE INFORMATION PROVIDED. 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 CUSTOMER SERVICE THAT SHE HAS HAD A SERIOUS ALLERGIC REACTION SINCE USING A HOSPITAL GRADE MEDELA SYMPHONY PUMP. HER DOCTOR SAID IT MAY BE A LATEX ALLERGY. SHE IS QUESTIONING WHETHER OR NOT THERE IS LATEX IN MEDELA BREAST PUMP KITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64233 SYMPHONY BREAST PUMP HGX MEDELA A G 015XX/024XXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other