BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTSPAN TISSUE EXPANDER

    MDR report key: 1641351 · Received March 24, 2010

    Report

    Report Number
    3031984-2010-00002
    Event Type
    Injury
    Date Received
    March 24, 2010
    Date of Event
    May 22, 2009
    Report Date
    March 23, 2010
    Manufacturer
    SPECIALTY SURGICAL PRODUCTS, INC.
    Product Code
    LCJ
    PMA / PMN Number
    K974209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO ADDITIONAL DEVICES FROM THE ASSOCIATED BATCH ARE AVAILABLE FOR EVALUATION. ASSOCIATED BATCH RECORDS WERE REVIEWED AND DOCUMENTATION VERIFIED THE DEVICES WERE PROCESSED PER APPROVED PROCESSES AND STERILIZED IN ACCORDANCE WITH THE VALIDATED GAMMA RADIATION STERILIZATION PROCESS. THE CERTIFIED DOSE WAS VERIFIED TO MEET APPROVED VALIDATED REQUIREMENTS. NO OTHER INFECTIONS ASSOCIATED WITH THIS BATCH HAVE BEEN REPORTED. NO OTHER REPORTS OF SIMILAR INFECTIONS HAVE BEEN REPORTED. NO INDICATION TO SUPPORT THE DEVICE WAS RESPONSIBLE FOR THE REPORTED INFECTION.

    Description of Event or Problem · 1

    DEVICE 2 (REFERENCE MFR REPORT # 3031984-2010-00001). ON (B) (6) 2009, TWO EXPANDERS WERE IMPLANTED IN PATIENT'S NECK/HEAD REGION FOR FLAP DEVELOPMENT AS PART OF PLANNED TREATMENT OF ALOPECIA. PATIENT WAS DISCHARGED AND SENT HOME. ON (B) (6) 2009, PATIENT WAS ADMITTED FOR EXPANDER REMOVAL DUE TO APPARENT INFECTION. CULTURE WAS TAKEN AND TESTED POSITIVE FOR ASB (MYCOBACTERIUM). ON (B) (6) 2009, PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTSPAN TISSUE EXPANDER TISSUE EXPANDER LCJ SPECIALTY SURGICAL PRODUCTS, INC. BTE070 9C131

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R