BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SORBACT GEL DRESSING

    MDR report key: 8599199 · Received May 10, 2019

    Report

    Report Number
    8043991-2019-00001
    Event Type
    Injury
    Date Received
    May 10, 2019
    Date of Event
    July 31, 2018
    Report Date
    May 7, 2019
    Manufacturer
    ABIGO MEDICAL AB
    Product Code
    FRO
    PMA / PMN Number
    K100591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER AN EPIDERMAL INFLAMMATORY REACTION AND ENLARGEMENT OF ULCEROUS LESIONS WAS OBSERVED AFTER 21 DAYS OF TREATMENT OF A WOUND WITH SORBACT GEL DRESSING. SORBACT GEL DRESSING WAS COVERED WITH A WET COMPRESS AND MAINTAINED BY RESPOSORB DURING TREATMENT. BURNING SENSATION AND PAIN WAS ALSO REPORTED. NO FEVER. HOSPITALIZATION WAS REQUIRED. AFTER STOP USING SORBACT GEL DRESSING THE INFLAMMATORY REACTION WAS AMPLIFIED DURING 3 DAYS AND THEREAFTER STOPPED. THE SORBACT GEL DRESSING WAS CHANGED DAILY DURING TREATMENT. MANY GEL DRESSINGS (NO INFORMATION ON THE NUMBER OF PRODUCTS) WERE APPLIED ON THE VENOUS ULCER WHICH COVERED A LARGE PART OF THE CALF AND TIBIA. THE VENOUS ULCER WAS VERY DIFFUSE SO PRODUCTS WERE NOT APPLIED ONLY TO THE WOUND BUT ALSO TO THE SURROUNDING SKIN. NO CREAM OR GELS WERE USED SIMULTANEOUSLY BUT A COMPRESSION WITH URGOK2 WAS IMPLEMENTED. THE NURSE DID NOT FOLLOW THE PATIENT AGAIN AND SO SHE DOES NOT HAVE MORE DATA REGARDING THE LENGTH OF HOSPITALIZATION NOR THE PATIENT'S RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393254 SORBACT GEL DRESSING DRESSING, WOUND, DRUG FRO ABIGO MEDICAL AB 7.5X7.5 CM 8112

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization