BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS AVENT TWIN ELECTRIC BREAST PUMP

    MDR report key: 12079731 · Received June 28, 2021

    Report

    Report Number
    3010359222-2021-00002
    Event Type
    Injury
    Date Received
    June 28, 2021
    Report Date
    April 6, 2023
    Manufacturer
    PHILIPS CONSUMER LIFESTYLE B.V.
    Product Code
    HGX
    PMA / PMN Number
    K201381
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS NOT COMPLETED THE INVESTIGATION OF THIS EVENT. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION. PAIN AND BRUISES ON THE NIPPLES 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. ALSO 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. FOLLOW-UP 8/6/2021 THE DEVICE WAS RETURNED AND INVESTIGATED. ON THE 3RD OF AUGUST THE TEAM HAS PROVIDED THE TECHNICAL REPORT AND THE DEVICE IS PERFORMING AS PER SPECIFICATION. NO ANOMALY WAS DETECTED. WE CONCLUDE THAT PAIN AND BRUISES ON THE NIPPLES 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. ON 4/06/2023: DURING QUALITY REVIEW OF THIS CASE AND MDR SUBMISSIONS, IT WAS FOUND THAT THE ORGIFNAL FOLLOW-UP SUBMISSION WAS REJECTED BY THE WEBTRADER SYSTEM. THIS IS BEING RESENT TO ENSURE FDA RECEIPT.

    Description of Event or Problem · 0

    A CUSTOMER CLAIMS THAT SHE GOT BRUISES ON HER NIPPLE AND AREOLA AFTER USING THE BREAST PUMP. THE DAMAGES ON HER SKIN ARE, ACCORDING TO THE CUSTOMER, PERMANENT. NO MEDICAL ATTENTION WAS SOUGHT. DATE OF INCIDENT IS UNKNOWN. DEVICE EXPIRATION DATE IS NOT APPLICABLE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS NOT COMPLETED THE INVESTIGATION OF THIS EVENT. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION. PAIN AND BRUISES ON THE NIPPLES 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. ALSO 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.

    Description of Event or Problem · 1

    A CUSTOMER CLAIMS THAT SHE GOT BRUISES ON HER NIPPLE AND AREOLA AFTER USING THE BREAST PUMP. THE DAMAGES ON HER SKIN ARE, ACCORDING TO THE CUSTOMER, PERMANENT. NO MEDICAL ATTENTION WAS SOUGHT. DATE OF INCIDENT IS UNKNOWN. DEVICE EXPIRATION DATE IS NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975966 PHILIPS AVENT TWIN ELECTRIC BREAST PUMP BREAST PUMP, PRODUCT CODE HGX HGX PHILIPS CONSUMER LIFESTYLE B.V. SCF334/22

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention