BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEL

    MDR report key: 299562 · Received October 4, 2000

    Report

    Report Number
    MW1020110
    Event Type
    Injury
    Date Received
    October 4, 2000
    Date of Event
    October 4, 2000
    Report Date
    October 4, 2000
    Manufacturer
    GORE
    Product Code
    KIA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT HAD METATARSAL FRACTURES AND A FIBERGLASS CAST WITH PROCEL WATERPROOF LINING PLACED ON THE RIGHT FOOT. PT COMPLAINED OF BURNING AND PAIN AND THE CAST WAS REMOVED 2 WEEKS LATER BY THE SURGEON, REVEALING 2ND DEGREE BURNS ON THE TOP AND SIDE OF THE FOOT REQUIRING IMMEDIATE BURN WOUND CARE AT HOSP. ONE POSSIBLE CAUSE OF THE WOUND IS AN ALLERGY TO THE PROCEL LINING SINCE THE PT HAS HAD PREVIOUS FIBERGLASS CASTS WITH NO ALLERGIC RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEL WATERPROOF CAST LINER KIA GORE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention