BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-STRATIS

    MDR report key: 2940791 · Received August 22, 2006

    Report

    Report Number
    3004824670-2006-00001
    Event Type
    Injury
    Date Received
    August 22, 2006
    Date of Event
    July 5, 2006
    Report Date
    August 21, 2006
    Manufacturer
    SCANDIUS BIOMEDICAL, INC.
    Product Code
    MAI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT REPORTED AS "RECOVERING WELL". DEVICE WAS USED SUCCESSFULLY TO PERFORM ACL RECONSTRUCTION AND REMAINS IN PT. REFERENCE REPORT # 3004824670-2006-00003.

    Description of Event or Problem · 1

    INFECTION FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-STRATIS ABSORBABLE ACL RECONSTRUCTION SYSTEM MAI SCANDIUS BIOMEDICAL, INC. NA 1181

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention