BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATIS

    MDR report key: 3089432 · Received December 29, 2006

    Report

    Report Number
    3004824670-2006-00004
    Event Type
    Injury
    Date Received
    December 29, 2006
    Date of Event
    October 22, 2006
    Report Date
    December 29, 2006
    Manufacturer
    SCANDIUS BIOMEDICAL, INC.
    Product Code
    HWC
    PMA / PMN Number
    K041961
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFECTION FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATIS ABSORBABLE RECONSTRUCTION SYSTEM HWC SCANDIUS BIOMEDICAL, INC. NA 1125

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention