BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS AVENT DOUBLE ELECTRIC BREAST PUMPS

    MDR report key: 6188454 · Received December 20, 2016

    Report

    Report Number
    8021997-2016-00006
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    PHILIPS ELECTRONICS UK LIMITED
    Product Code
    HGX
    PMA / PMN Number
    K161532
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION OF A SYSTEMIC PROBLEM OR EMERGING ISSUE INVOLVING THE SAME SYMPTOM AND FAILURE MODE OVER THE PAST YEAR. USE OF BREAST PUMPS IS NOT KNOWN TO CAUSE OR CONTRIBUTE TO THIS EVENT. THIS REPORT HAS BEEN SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW OF PAST COMPLAINTS. DEVICE NOT RETURNED BY THE CONSUMER.

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION OF A SYSTEMIC PROBLEM OR EMERGING ISSUE INVOLVING THE SAME SYMPTOM AND FAILURE MODE OVER THE PAST YEAR. USE OF BREAST PUMPS IS NOT KNOWN TO CAUSE OR CONTRIBUTE TO THIS EVENT. THIS REPORT HAS BEEN SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW OF PAST COMPLAINTS. CORRECTED DATA: INDICATED THAT THE MANUFACTURER WAS LOCATED IN THE US INSTEAD OF THE (B)(6).

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION OF A SYSTEMIC PROBLEM OR EMERGING ISSUE INVOLVING THE SAME SYMPTOM AND FAILURE MODE OVER THE PAST YEAR. USE OF BREAST PUMPS IS NOT KNOWN TO CAUSE OR CONTRIBUTE TO THIS EVENT. THIS REPORT HAS BEEN SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW OF PAST COMPLAINTS CORRECTED DATA: INDICATED THAT THE MANUFACTURER WAS LOCATED IN THE US INSTEAD OF THE (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER CLAIMS THE POWER BUTTON STOPPED WORKING ON THE BREAST PUMP,MEANING SHE WAS UNABLE TO PUMP AS OFTEN AS SHE NEEDED. THEN SHE GOT MASTITIS AND HAD TO SEEK MEDICAL ATTENTION.

    Description of Event or Problem · 1

    THE CONSUMER CLAIMS THE POWER BUTTON STOPPED WORKING ON THE BREAST PUMP, MEANING SHE WAS UNABLE TO PUMP AS OFTEN AS SHE NEEDED. THEN SHE GOT MASTITIS AND HAD TO SEEK MEDICAL ATTENTION.

    Description of Event or Problem · 1

    THE CONSUMER CLAIMS THE POWER BUTTON STOPPED WORKING ON THE BREAST PUMP, MEANING SHE WAS UNABLE TO PUMP AS OFTEN AS SHE NEEDED. THEN SHE GOT MASTITIS AND HAD TO SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839482 PHILIPS AVENT DOUBLE ELECTRIC BREAST PUMPS ELECTRIC BREAST PUMP HGX PHILIPS ELECTRONICS UK LIMITED SCF334

    Patients

    Seq Age Sex Outcome Treatment
    1 Other