BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE BREAST PUMP

    MDR report key: 2050772 · Received March 31, 2011

    Report

    Report Number
    1419937-2011-00053
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    January 28, 2011
    Report Date
    March 4, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INITIALLY CONTACTED CUSTOMER SERVICE ON (B)(6) 2011 WITH A REPORT OF LOSS OF SUCTION ON ONE SIDE (SHE COULD SINGLE PUMP BUT NOT DOUBLE PUMP). THE CUSTOMER DID NOT REPORT MASTITIS. TROUBLESHOOTING INDICATED THAT THE FACEPLATE WOULD NOT SNAP ON TIGHTLY. THE FACEPLATE WAS REPLACED AT THAT TIME. THE CUSTOMER CONTACTED CUSTOMER SERVICE AGAIN ON (B)(6) 2011 WITH A REPORT OF LOSS OF SUCTION ON ONE SIDE. THE CUSTOMER DID NOT REPORT MASTITIS. AS A RESULT OF TROUBLESHOOTING, THE CUSTOMER WAS SENT NEW TUBING, VALVES AND MEMBRANES. FINALLY, THE CUSTOMER CONTACTED CUSTOMER SERVICE ON (B)(6) 2011, AGAIN REPORTING A LOSS OF SUCTION. AT THIS TIME, SHE INDICATED THAT SHE WAS HAVING ISSUES WITH MASTITIS. THE PUMP WAS REPLACED FOR THE CUSTOMER. ATTEMPTS TO CONTACT THIS CUSTOMER TO GET ADDITIONAL INFORMATION RELATIVE TO HER COMPLAINT, INCLUDING MEDICAL TREATMENT, IF ANY, AND TO GET THE PRODUCT BACK HAVE BEEN UNSUCCESSFUL. WE WILL CONTINUE TO ATTEMPT TO MAKE CONTACT WITH THIS CUSTOMER. BECAUSE, THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE REC'D, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A F/U REPORT WILL BE FILED. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SHE IS EXPERIENCING LOSS OF SUCTION USING HER PUMP IN STYLE BREAST PUMP AND SHE IS ON HER THIRD ROUND OF MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE BREAST PUMP HGX MEDELA, INC. 57027

    Patients

    Seq Age Sex Outcome Treatment
    1