BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKIN PREP 4.25OZ SPR

    MDR report key: 5301942 · Received December 16, 2015

    Report

    Report Number
    3006760724-2015-00120
    Event Type
    Injury
    Date Received
    December 16, 2015
    Date of Event
    December 5, 2015
    Report Date
    December 7, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NEC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADVERSE SKIN REACTION WAS REPORTED WHILST USING THIS PRODUCT, SKIN BECAME ITCHY. WAFER HAD TO BE REMOVED DUE TO PRURITUS AND RASH WAS NOTED. PRODUCT HAD BEEN USED BEYOND EXPIRATION DATE OF 02/2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829805 SKIN PREP 4.25OZ SPR BANDAGE, LIQUID, SKIN PROTECTANT. NEC SMITH & NEPHEW, INC. 420200 522114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other