BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACOL 15X20 1.5MM

    MDR report key: 5201644 · Received November 4, 2015

    Report

    Report Number
    9615742-2015-00102
    Event Type
    Injury
    Date Received
    November 4, 2015
    Date of Event
    October 7, 2015
    Report Date
    November 12, 2015
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OXK
    PMA / PMN Number
    K120605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR INVESTIGATION. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN PERFORMED. THIS REVIEW CONFIRMED THAT THIS LOT OF PRODUCTS WAS RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH OF THE GLOBAL COMPLAINTS DATABASE REVEALED THAT THIS WAS THE ONLY REPORT ON FILE FOR THIS LOT OF PRODUCT. THE REPORT HAS BEEN ADDED TO THE PRODUCT COMPLAINTS DATABASE WHICH IS MONITORED FOR SIMILAR OCCURRENCES.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, FOLLOWING A PROCEDURE TO RESECT A TUMOR AND REPAIR AN ABDOMINAL EVISCERATION, A MESH IMPLANT WAS PLACED AND PROPHYLACTIC ANTIBIOTIC THERAPY WAS STARTED. 24 HOURS FOLLOWING THE PROCEDURE, THE PATIENT PRESENTED WITH PAINFUL EDEMA, ERYTHEMA AND FEVER. IT WAS DIAGNOSED AS BACTEREMIA AND NECROTIZING FASCIITIS. ANOTHER ANTIBIOTIC WAS ADDED TO THE THERAPY AND THE PATIENT WAS TAKEN TO SURGERY. NOTHING ABNORMAL WAS FOUND DURING SURGERY. CULTURES WERE TAKEN FROM THE EDGES OF THE DEFECT AND SENT TO PATHOLOGY. KLEBSIELLA PNEUMONIAE (A NOSOCOMIAL GERM) WAS FOUND AND THE PATHOLOGY RESULTS ARE PENDING. THE PATIENT REMAINS IN THE INTENSIVE CARE UNIT (ICU). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731574 PERMACOL 15X20 1.5MM MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS OXK SOFRADIM PRODUCTION 5152-150 AOG0669

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R