BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLEX BREAST PUMP EN FR ES

    MDR report key: 10868951 · Received November 19, 2020

    Report

    Report Number
    1419937-2020-00131
    Event Type
    Injury
    Date Received
    November 19, 2020
    Date of Event
    October 28, 2020
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    UDI-DI
    00020451379807
    PMA / PMN Number
    K191653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020, THE CUSTOMER CALLED MEDELA LLC AFTER MEDELA CUSTOMER SERVICE RESPONDED TO HER EMAIL ASKING HER TO CONTACT US VIA PHONE OR CHAT TO BETTER ADDRESS HER ISSUE. THE CUSTOMER INDICATED THAT SHE USED THE REGULAR PERSONALFIT BREAST SHIELDS BEFORE WITH NO ISSUE AND THINKS IT MAY BE CAUSED BY THE SILICONE ON THE FLEX SHIELDS. SHE ALSO INDICATED THE SHE SAW HER DOCTOR AND WAS PRESCRIBED A STEROID CREAM. CUSTOMER SERVICE SENT THE CUSTOMER THE PERSONALFIT BREAST SHIELDS. IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2020, THE CUSTOMER INDICATED THAT SHE RESPONDED TO A TWO WEEK COURSE OF A TOPICAL PRESCRIPTION STRENGTH STEROIDS AND INDICATED THAT THE CONTACT DERMATITIS WAS NOW IMPROVED. THE CUSTOMER ALSO INDICATED THAT SHE WASHED THE BREAST SHIELDS DAILY IN THE DISHWASHER AND LET THEM AIR DRY. SHE ALSO STATED THAT SHE IS USING THE PERSONALFIT BREAST SHIELDS WITH NO ISSUES. MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION (MEDICATION WAS PRESCRIBED).

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE CUSTOMER ALLEGED VIA EMAIL TO MEDELA LLC THAT SHE DEVELOPED A SEVERE CASE OF CONTACT DERMATITIS ON HER CHEST FROM THE FREESTYLE FLEX BREAST SHIELD, WHILE PUMPING WITH THE FREESTYLE FLEX BREAST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336627 FREESTYLE FLEX BREAST PUMP EN FR ES PUMP, BREAST, POWERED HGX MEDELA AG 101037980 NI 00020451379807

    Patients

    Seq Age Sex Outcome Treatment
    1 Other