BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSTEAD SOFTCUP

    MDR report key: 329363 · Received April 26, 2001

    Report

    Report Number
    3026654-2001-00006
    Event Type
    Other
    Date Received
    April 26, 2001
    Date of Event
    April 4, 2001
    Report Date
    April 17, 2001
    Manufacturer
    ULTRAFEM, INC.
    Product Code
    HHE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER SAID THEY HAD AN ALLERGIC REACTION WHICH CUSTOMER THINKS WAS CAUSED BY USING THE INSTEAD SOFTCUP. CUSTOMER CALLED SAID THEY HAD USED 6 CUPS FOR THEIR 1ST PERIOD, AND CUSTOMER WAS FINE. THEN CUSTOMER BOUGHT A LARGER BOX AND USED THEM FOR THEIR 2ND PERIOD. CUSTOMER THEN EXPERIENCED A REACTION - PAIN. CUSTOMER IS SEEING REGULAR PHYSICIAN AND OBGYN. CUSTOMER STATED CUSTOMER IS VERY SENSITIVE AND CUSTOMER HAS REACTED TO CONDOMS. COMPANY REQUESTED CUSTOMER'S RECORDS, BILLS, THE CARTON AND REMAINING CUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19302 INSTEAD SOFTCUP MENSTRUAL COLLECTION CUP HHE ULTRAFEM, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention