BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE BREAST PUMP

    MDR report key: 2120137 · Received June 6, 2011

    Report

    Report Number
    1419937-2011-00128
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    January 25, 2010
    Report Date
    May 4, 2011
    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

    CUSTOMER SERVICE SENT A REPLACEMENT PUMP TO THE CUSTOMER ON (B)(6) 2010. THE CUSTOMER CONTACTED MEDELA AGAIN ON (B)(6) 2010 AND INDICATED THAT SHE HAD NOT BEEN TAKING APART THE MEMBRANE, CONNECTOR, AND BACK CAP AND CLEANING THEM. NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AT THAT TIME. DURING REMEDIATION ACTIVITIES, A DECISION WAS MADE ON (B)(6) 2011, BASED ON THE INFORMATION AVAILABLE, THAT THE ISSUE WAS NOT A REPORTABLE EVENT. THE CUSTOMER CONTACTED MEDELA AGAIN ON (B)(6) 2011 REGARDING A NEW ISSUE WITH HER REPLACEMENT PUMP. WHEN DESCRIBING HER (B)(6) 2011 ISSUE, SHE REFERRED BACK TO HER (B)(6) 2010 ISSUE AND INDICATED THAT SHE STOPPED PUMPING SHORTLY AFTER THE ISSUE "BECAUSE DUE TO THE PUMP I GOT A SEVERE BREAST INFECTION AND I HAD TO STOP NURSING MY BABY." NO OTHER DETAILS REGARDING THE ISSUE WERE PROVIDED. THE PUMP WAS RETURNED ON (B)(6) 2010, TESTED, AND SCRAPPED; TESTING SHOWED THE PUMP WAS FUNCTIONING PROPERLY. BECAUSE OF THE NEW INFORMATION RELATING TO THE (B)(6) 2010 COMPLAINT REGARDING THE BREAST INFECTION, A SECONDARY REVIEW OF THIS INFORMATION WAS PERFORMED ON (B)(6) 2011 WAS FOUND TO BE REPORTABLE. AS THERE WAS NO PRODUCT FAULT FOUND, IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER'S BREAST INFECTION. SHOULD NEW, CHANGED, OR CORRECTED INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED AT THAT TIME. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED ON (B)(6) 2010 THAT SHE HAD BEEN USING HER BREAST PUMP WITH NO PROBLEMS FOR 10 MONTHS, BUT WHEN SHE WENT TO PUMP ON (B)(6) 2010, IT HURT AND SHE NOTICED BLOOD IN THE BOTTLE. HER NIPPLE WAS FINE BUT THE BREAST AREA WAS SORE. WHEN SHE WENT TO PUMP AGAIN ON (B)(6) 2010, THE SAME THING HAPPENED. SHE INDICATED THAT THE BABY WAS NURSING FINE AND THAT SHE DID NOT SEE A LACTATION CONSULTANT OR DOCTOR REGARDING THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other