BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHOULDER ARTHROSCOPY (SAOOA)647

    MDR report key: 858524 · Received May 31, 2007

    Report

    Report Number
    1423507-2007-00083
    Event Type
    Other
    Date Received
    May 31, 2007
    Date of Event
    May 4, 2007
    Report Date
    May 31, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER OF COMPONENT 0523-48, MASTISOL ADHESIVE SOLUTION, FERNDALE LABORATORY OUT OF FERNDALE MICHIGAN HAS DECLINED TO SUBMIT AN MDR. CARDINAL HEALTH IS SUBMITTING AS THE CONVENIENCE KIT PACKAGER. PER FERNDALE LABORATORY: PRODUCTION RECORDS SHOW LOT 06004B WAS MANUFACTURED IN ACCORDANCE WITH GOOD MANUFACTURING PRACTICES AND ALL LABORATORY TESTING FOR LOT 08004B MET FERNDALE LABORATORIES FINISHED PRODUCT SPECIFICATIONS FOR MASTISOL AND RESULTS WERE DEEMED ACCEPTABLE AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS, THAT IN 4 INSTANCES WITHIN THE LAST WEEK, A PATIENT HAS EXPERIENCED DERMATITIS AT THE SITE OF SHOULDER ARTHROSCOPY AS A RESULT OF BEING EXPOSED TO 0523-48: MASTISOL ADHESIVE SOLUTION. A TOPICAL CORTISOL PRESCRIPTION WAS USED TO PREVENT ITCHING. ALL PATIENTS HAVE HAD RESOLUTION OF THE DERMATITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHOULDER ARTHROSCOPY (SAOOA)647 SHOULDER ARTHROSCOPY HRX CARDINAL HEALTH SOP53SAOOB 204888

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention