BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUBRICATING GEL 0F2

    MDR report key: 2974249 · Received February 14, 2013

    Report

    Report Number
    2434221-2013-00001
    Event Type
    Other
    Date Received
    February 14, 2013
    Date of Event
    January 20, 2013
    Report Date
    February 14, 2013
    Manufacturer
    PERRIGO NEW YORK, INC.
    Product Code
    KMJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM THE HUSBAND OF (B)(6) MALE REGARDING LUBRICATING GEL. ON (B)(6) 2013 THE CONSUMER USED AN APPLICATION FOR PERSONAL LUBRICATION AND WITHIN 10 MINS OF APPLICATION AND SEXUAL INTERCOURSE HE DEVELOPED AN ALLERGIC REACTION WITH A BURNING SENSATION, WELTS, RASH AND SWELLING OF THE GENITAL AREA. THE CONSUMER WAS TREATED ON (B)(6) 2013 IN AN EMERGENCY ROOM WITH AN UNSPECIFIED STEROID INJECTION AND ANOTHER UNSPECIFIED MEDICATION. HE WAS DISCHARGED ON (B)(6) 2013, AFTER 4-5 HOURS IN THE EMERGENCY ROOM, WITH THE DIAGNOSIS OF RASH AND ALLERGIC REACTION. HE WAS GIVEN ORDERS TO TAKE BENADRYL AND AN UNSPECIFIED STEROID. THE BURNING SENSATION AND GENITAL SWELLING RESOLVED ON (B)(6) 2013; THE RASH AND ALLERGIC REACTION RESOLVED ON (B)(6) 2013. THE CONSUMER REPORTED NO KNOWN DRUG ALLERGIES. MEDICAL CONFIRMATION IS BEING SOUGHT. SEE MFR REPORT 2434221-2013-00002 FOR A REPORT REGARDING THE CONSUMER'S SPOUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66300 LUBRICATING GEL 0F2 LUBRICATING JELLY KMJ PERRIGO NEW YORK, INC. 2KT0284

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention NONE REPORTED