BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS AVENT MANUAL BREAST PUMP

    MDR report key: 14787315 · Received June 23, 2022

    Report

    Report Number
    3010359222-2022-00001
    Event Type
    Injury
    Date Received
    June 23, 2022
    Report Date
    October 14, 2022
    Manufacturer
    PHILIPS CONSUMER LIFESTYLE B.V.
    Product Code
    HGY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE LIMITED INFORMATION PROVIDED BY THE CUSTOMER, WE ARE ATTEMPTING TO RETRIEVE THE DEVICE FOR A FORMAL INVESTIGATION. HOWEVER WE KNOW THAT PAIN AND BRUISEES ARE KNOWN SIDE EFFECTS OF NATURAL BREAST FEEDING AND ALSO KNOWN SIDE EFFECTS OF USING BREAST PUMPS. THE DEVICE HAS BEEN DESIGNED ACCORDING TO SAFETY STANDARDS AND IS SAFE TO USE WHEN USED ACCORDING TO THE DFU.

    Additional Manufacturer Narrative · 0

    BASED ON THE LIMITED INFORMATION PROVIDED BY THE CUSTOMER, WE ARE ATTEMPTING TO RETRIEVE THE DEVICE FOR A FORMAL INVESTIGATION. HOWEVER WE KNOW THAT PAIN AND BRUISES ARE KNOWN SIDE EFFECTS OF NATURAL BREAST FEEDING AND ALSO KNOWN SIDE EFFECTS OF USING BREAST PUMPS. THE DEVICE HAS BEEN DESIGNED ACCORDING TO SAFETY STANDARDS AND IS SAFE TO USE WHEN USED ACCORDING TO THE DFU. FOLLOW UP #1: THE DEVICE WAS RETURNED TO PHILIPS FOR INVESTIGATION AND WAS FOUND TO BE PERFORMING AS PER SPECIFICATION. NO PRODUCT ANOMALIES WERE FOUND. PAIN AND NIPPLE TRAUMA ARE COMMON SIDE EFFECTS OF NATURAL BREAST FEEDING AND ALSO KNOWN SIDE EFFECTS OF USING BREAST PUMPS. 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 · 0

    THE CUSTOMER STATED THAT AFTER USING THE MANUAL BREAST PUMP, SHE HAD PAIN IN HER BREAST. SHE ALSO FELT CONGESTION IN THE BREAST, FELT LUMPS AROUND AREOLA AND SIDE OF LEFT BREAST. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT AFTER USING THE MANUAL BREAST PUMP, SHE HAD PAIN IN HER BREAST. SHE ALSO FELT CONGESTION IN THE BREAST, FELT LUMPS AROUND AREOLA AND SIDE OF LEFT BREAST. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277406 PHILIPS AVENT MANUAL BREAST PUMP BREAST PUMP, MANUAL HGY PHILIPS CONSUMER LIFESTYLE B.V. SCF430/10

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other