BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANCHOR FIX UNDERWRAP

    MDR report key: 2640046 · Received August 26, 2011

    Report

    Report Number
    2939821-2011-00005
    Event Type
    Other
    Date Received
    August 26, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 23, 2011
    Manufacturer
    PHARMACARE, LTD
    Product Code
    ILH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    AFTER WEARING THE ANCHOR FIX UNDERWRAP, THE PT DEVELOPED SOME RASHES. ANCHOR FIX UNDERWRAP IS A LATEX FREE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR FIX UNDERWRAP FABRIC UNDERWRAP ILH PHARMACARE, LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other