BEUDAMED
    FDA Adverse Event Other Summary report: N

    SINGLE DELUXE BREASTPUMP

    MDR report key: 1880477 · Received October 13, 2010

    Report

    Report Number
    1419937-2010-00006
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    June 20, 2010
    Report Date
    June 28, 2010
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K901344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT WANT A REPLACEMENT PUMP. THE DEVICE WAS RETURNED FOR EVALUATION/INVESTIGATION. THE VACUUM TRACE WAS MONITORED AND FOUND TO BE CYCLING ABNORMALLY. IT SEEMED THE POWER SWITCH WAS NOT OPERATING CORRECTLY, AND ON THE LOW SETTING WOULD PROVIDE INTERMITTENT POWER TO THE MOTOR. IN SOME CASES, THE SWITCH WOULD PROVIDE A BURST OF POWER TO THE DRAW VACUUM AND THEN STALL PRIOR TO VACUUM RELEASE. THERE IS A "NATURAL" LEAKAGE THAT OCCURS, SO THE VACUUM WOULD EVENTUALLY RELEASE. WHILE THE DEVICE DID NOT TEST TO SPECIFICATIONS, NO DEFINITIVE CONCLUSION REGARDING THE CAUSE OF THE REPORTED EVENT CAN BE DETERMINED. 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

    THE CUSTOMER PURCHASED THE PUMP ON 15TH. THE CUSTOMER REPORTS THE FIRST AND ONLY TIME THAT SHE USED THE PUMP (APPROXIMATELY JUNE 20TH), HER NIPPLE WAS SUCTIONED INTO THE PUMP AND WAS NOT RELEASED. THIS RESULTED IN THE NIPPLE BLEEDING AND IT IS NOW CRACKED. SHE SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED ANTIBIOTICS AND A PAIN KILLER. HER NIPPLE IS INFECTED. SHE STATED IT WAS VERY TRAUMATIC AND PAINFUL. THE CUSTOMER IS NOT SURE OF THE EXACT DATE OF INCIDENT, AS SHE HAS BEEN BUSY WITH HER BABY AND THIS IS THE FIRST CHANCE SHE HAD TO CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE DELUXE BREASTPUMP PUMP, BREAST, POWERED HGX MEDELA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other