BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS AVENT COMFORT MANUAL BREAST PUMP

    MDR report key: 12584699 · Received October 6, 2021

    Report

    Report Number
    3010359222-2021-00004
    Event Type
    Injury
    Date Received
    October 6, 2021
    Report Date
    November 23, 2021
    Manufacturer
    PHILIPS CONSUMER LIFESTYLE B.V.
    Product Code
    HGY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS MAKING AN EFFORT TO RETRIEVE THE DEVICE FOR INVESTIGATION. WE ARE REPORTING THIS EVENT BECAUSE BASED ON THE CURRENT AVAILABLE INFORMATION THE PATIENT WAS TREATED TO PREVENT POTENTIAL SERIOUS INJURY. UPDATE 11/23/2021: THE DEVICE WAS RETURNED TO PHILIPS FOR INVESTIGATION. THE DEVICE PERFORMANCE WAS WITHIN SPECIFICATIONS. NO ANOMALY WAS DETECTED. BASED ON THE INFORMATION PROVIDED BY THE CONSUMER, IT IS NOT CLEAR WHETHER THE CONSUMER SUFFERED FROM MASTITIS. MASTITIS IS A SECONDARY COMPLICATION OF KNOWN SIDE EFFECTS OF USING A BREAST PUMP AND OF BREASTFEEDING. PAIN, BRUISING, NIPPLE TRAUMA, THROMBUS, RASH ARE KNOWN SIDE EFFECTS OF NATURAL BREAST FEEDING AND ALSO KNOWN SIDE EFFECTS OF USING BREAST PUMPS. WE KNOW THAT A SLIGHT CHANGE OF THE POSITION DURING USING OF THE DEVICE MAY HELP TO AVOID PAIN AS WELL AS A LARGER CUSHION CAN HELP. THE DEVICE HAS BEEN DESIGNED ACCORDING TO SAFETY STANDARDS AND IS SAFE TO USE WHEN USED ACCORDING TO THE DFU. PHILIPS CONTINUES TO MONITOR THIS TYPE OF EVENTS AS PART OF THE POST MARKET SURVEILLANCE PROCESS ACTIVITIES.

    Description of Event or Problem · 0

    BREAST PUMP CAUSED A RED MARK ON SKIN. THE USER SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED ANTIBIOTICS.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS MAKING AN EFFORT TO RETRIEVE THE DEVICE FOR INVESTIGATION. WE ARE REPORTING THIS EVENT BECAUSE BASED ON THE CURRENT AVAILABLE INFORMATION THE PATIENT WAS TREATED TO PREVENT POTENTIAL SERIOUS INJURY.

    Description of Event or Problem · 1

    BREAST PUMP CAUSED A RED MARK ON SKIN. THE USER SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480414 PHILIPS AVENT COMFORT MANUAL BREAST PUMP MANUAL BREAST PUMP HGY PHILIPS CONSUMER LIFESTYLE B.V. SCF330/30

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other