BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPERM

    MDR report key: 6871872 · Received September 18, 2017

    Report

    Report Number
    1218946-2017-00001
    Event Type
    Injury
    Date Received
    September 18, 2017
    Date of Event
    August 11, 2017
    Report Date
    August 26, 2017
    Manufacturer
    HARTMANN USA
    Product Code
    ILG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OCCUPATIONAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE PRODUCT, PATIENT AGE, WEIGHT, ETHNICITY/RACE OR SEX WAS NOT GIVEN BY THE CUSTOMER. HARTMANN USA HAS UPDATED THE PRODUCT LITERATURE TO STATE THE PRODUCT CONTAINS POLYESTER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO FIND OUT IF COMPERM CONTAINED POLYESTER OR NYLON. THE CUSTOMER USED COMPERM ON A PATIENT WITH KNOWN ALLERGIES TO NYLON AND POLYESTER AND THE PATIENT HAD AN ALLERGIC REACTION. THE SKIN PRODUCED A RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654267 COMPERM STOCKING, ELASTIC ILG HARTMANN USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other