BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SKIN PREP OR REMOVER WIPE PRODUCT

    MDR report key: 6173189 · Received December 14, 2016

    Report

    Report Number
    8043484-2016-00176
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    December 8, 2016
    Report Date
    May 5, 2017
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADVERSE SKIN REACTION IT WAS REPORTED THAT A USER SUFFERED FROM A RASH AND ITCHING ON APPLICATION OF SKIN PREP WIPES OVER 3 MONTHS. THE PATIENT HAS TREATED HERSELF WITH HYDROCORTISONE 2.5 CREAM TO ALLEVIATE THE RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825070 UNKNOWN SKIN PREP OR REMOVER WIPE PRODUCT BANDAGE, LIQUID KMF SMITH & NEPHEW MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other