BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDER CARE HYDROGEL PADS

    MDR report key: 14516845 · Received May 26, 2022

    Report

    Report Number
    1419937-2022-00050
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 26, 2022
    Manufacturer
    MEDELA LLC
    Product Code
    NTC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER SERVICE SENT THE CUSTOMER SOME LANOLIN CREAM AND SUGGESTED SHE CONTACT HER DOCTOR. IN FOLLOW UP WITH A COMPLAINT HANDLER ON 5/3/2022, THE CUSTOMER STATED THAT SHE WENT TO THE DOCTOR AT 3 AM BECAUSE HER SKIN WAS BURNING AND SHE COULDN'T SLEEP. THE CUSTOMER INDICATED THAT SHE WAS CRYING AND THE DOCTOR PRESCRIBED HER CORTISONE TO APPLY ON BOTH BREAST, BUT IT DIDN¿T WORK. ADDITIONALLY, THE CUSTOMER INDICATED THAT AT 10 AM SHE WENT TO (B)(6) AND THE DOCTOR PRESCRIBED HER STEROIDS TO APPLY ON BOTH BREAST AS WELL, BUT IT DIDN'T WORK AGAIN . THE CUSTOMER ALSO STATED IT WASN'T AN ALLERGIC REACTION, THE HYDROGEL PADS BURNED MY SKIN. MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION (MEDICATION WAS PRESCRIBED).

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE HAD A REACTION TO THE HYDROGEL PADS AFTER WEARING THEM FOR TWO HOURS AND THE DOCTOR RECOMMENDED THAT SHE USE CORTISONE AND VASELINE BUT IT DIDN'T WORK. ADDITIONALLY, THE CUSTOMER ALLEGED THAT THE SKIN WHICH WAS UNDER THE PAD, INCLUDING THE NIPPLES, WAS BRIGHT RED, WITH RAISED BUMPS IN THE SHAPE OF THE MEDELA PAD ALONG WITH BURNING AND ITCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115063 TENDER CARE HYDROGEL PADS NURSING PAD, HYDROGEL NTC MEDELA LLC 87123

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other