BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIGRIP LATEX-FREE SIZE F - 4" X 10 METERS

    MDR report key: 11987165 · Received June 11, 2021

    Report

    Report Number
    9680091-2021-00008
    Event Type
    Injury
    Date Received
    June 11, 2021
    Report Date
    July 8, 2021
    Manufacturer
    DERMA SCIENCES, INC.
    Product Code
    MHW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGIGRIP LATEX-FREE WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE PRODUCT EVEN THOUGH IT SAYS LATEX FREE ON THE BOX. THE USER CLAIMS HER LEGS TURNED RED AND STARTED TO SWELL AFTER HAVING THIS ON ONLY FOR ABOUT AN HOUR AND HER SKIN WAS IRRITATED FOR A WHILE. SHE DOES HAVE AN ALLERGY TO LATEX. THE PRODUCT WAS USED FOR COMPRESSION ON LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877464 SURGIGRIP LATEX-FREE SIZE F - 4" X 10 METERS COMPRESSION PRODUCTS MHW DERMA SCIENCES, INC. 68570

    Patients

    Seq Age Sex Outcome Treatment
    1