BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP IN STYLE BREASTPUMP SHOULDER BAG

    MDR report key: 1880473 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00022
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENT TO THE INITIAL CALL FROM THE CUSTOMER, A MEDELA REPRESENTATIVE CONTACTED THE CUSTOMER TO OBTAIN THE DOCTOR INFORMATION THAT THE CUSTOMER HAD INDICATED SHE WOULD PROVIDE. THE CUSTOMER THEN REPORTED THAT SHE DID NOT SEE THE DOCTOR AND THAT SHE MIGHT HAVE MISUNDERSTOOD. THE CUSTOMER INDICATED THAT SHE STILL HAS A SCAB. THE ORIGINAL PUMP WAS RETURNED FOR EVALUATION/INVESTIGATION. VACUUM LEVELS AND CYCLES PER MINUTE WERE TESTED; ALL WERE WITHIN SPECIFICATIONS. NO DEFINITIVE CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. 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

    CUSTOMER PURCHASED THE PUMP ON (B)(6) 2010. THE CUSTOMER CLAIMS HER NIPPLES GOT DAMAGED. ONE IS CUT/TORN 180 DEGREES AND THE OTHER IS CUT AT THE TIP. SHE NEVER SAW ANY BLOOD, AND SHE PUMPED 3 TIMES ON (B)(6) 2010 FOR 5-10 MINUTES AT A MINIMUM LEVEL. CUSTOMER SAID SHE WILL CALL BACK WITH DOCTOR INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other