BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS AVENT NIPPLETTE

    MDR report key: 11563510 · Received March 24, 2021

    Report

    Report Number
    3010359222-2021-00001
    Event Type
    Injury
    Date Received
    March 24, 2021
    Report Date
    April 28, 2021
    Manufacturer
    PHILIPS CONSUMER LIFESTYLE B.V.
    Product Code
    HGY
    PMA / PMN Number
    K952035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE THE EFFORTS TAKEN BY PHILIPS TO RETRIEVE THE DEVICE AND GATHER MORE INFORMATION, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HAS BEEN DESIGNED ACCORDING TO APPLICABLE SAFETY STANDARDS AND IS SAFE WHEN USED AS DIRECTED BY THE INSTRUCTIONS FOR USE. ACCORDING TO THE WARNINGS THAT ARE INCLUDED IN OUR INSTRUCTIONS FOR USE, EXCESSIVE SUCTION FORCE APPLIED TO THE NIPPLE COULD CAUSE PAIN, BLISTERS, SWELLING, BLEEDING OR DISCHARGE OF FLUID. WE DIRECT THE USER TO DECREASE THE AMOUNT OF SUCTION AND IF THE SYMPTOMS PERSIST, TO CONTACT A HEALTHCARE PROFESSIONAL. WE CONSIDER THIS SPECIFIC COMPLAINT/EVENT CLOSED.

    Description of Event or Problem · 0

    CONSUMER CLAIMS AFTER SHE HAS USED THE NIPLETTES FOR ABOUT 2 WEEKS, HER NIPPLES HURT, GOT MISSHAPED AND TURNED PURPLE. HER DOCTOR TOLD HER IT WOULD TAKE MONTHS TO HEAL. CONSUMER ALSO THINKS SHE MIGHT NEED PLASTIC SURGERY.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN DESIGNED ACCORDING TO SAFETY STANDARDS AND IS SAFE TO USE WHEN USED ACCORDING TO THE DFU. THE DEVICE HAS BEEN REQUESTED FOR ANALYSIS.

    Description of Event or Problem · 1

    CONSUMER CLAIMS AFTER SHE HAS USED THE NIPLETTES FOR ABOUT 2 WEEKS, HER NIPPLES HURT, GOT MISSHAPED AND TURNED PURPLE. HER DOCTOR TOLD HER IT WOULD TAKE MONTHS TO HEAL. CONSUMER ALSO THINKS SHE MIGHT NEED PLASTIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460119 PHILIPS AVENT NIPPLETTE NIPLETTE HGY PHILIPS CONSUMER LIFESTYLE B.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other