BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDROGEL PADS

    MDR report key: 1899177 · Received October 29, 2010

    Report

    Report Number
    1419937-2010-00037
    Event Type
    Other
    Date Received
    October 29, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    MEDELA, INC
    Product Code
    NTC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITIONAL FOLLOW-UP, THE CUSTOMER STATED SHE WAS USING THE LANOLIN CREAM IN CONJUNCTION WITH BREASTFEEDING. HOWEVER, THE CREAM CAUSED A BURNING SENSATION WHICH CREATED PAIN WHEN THE BABY LATCHED ON. SHE STOPPED USING THE CREAM, STOPPED BREAST FEEDING, AND TURNED TO PUMPING EXCLUSIVELY (WITH A NON-MEDELA PUMP). THE MANUFACTURER REPRESENTATIVE WHO TOOK THE ORIGINAL CALL SENT THE CUSTOMER HYDROGEL PADS TO HELP WITH THE PAIN. ACCORDING TO THE CUSTOMER, THE PADS CREATED A SMALL, WHITE PUS-FILLED BOIL ON HER NIPPLE (SHE DESCRIBED IT AS BEING LIKE A WHITE HEAD AND A "LITTLE WHITE MARK"), WHICH WAS PAINFUL. SHE STOPPED USING THE HYDROGEL PADS AND CONSULTED A PHYSICIAN, WHO PRESCRIBED AN ANTIBIOTIC (KEFLEX, TAKEN ORALLY 4X A DAY FOR 7 DAYS) OVER THE PHONE, BASED ON HER SYMPTOMS, THINKING THERE COULD BE AN INFECTION. SHE HAS FINISHED THE ANTIBIOTIC AND CURRENTLY HAS NO ISSUES. SHE IS STILL PUMPING EXCLUSIVELY. THE ORIGINAL PRODUCTS WERE NOT RETURNED FOR EVALUATION/INVESTIGATION. THEREFORE, NO DEFINITIVE CONCLUSION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT CAN BE MADE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, WHEN USING THE LANOLIN CREAM, SHE FELT BURNING AND PAIN AS SOON AS THE BABY LATCHES ON. SHE SAID IT DOES GO AWAY, BUT IT IS PAINFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROGEL PADS NURSING PAD, HYDROGEL NTC MEDELA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other