BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 885823 · Received July 25, 2007

    Report

    Report Number
    2243569-2007-00003
    Event Type
    Other
    Date Received
    July 25, 2007
    Date of Event
    July 27, 2006
    Report Date
    July 15, 2007
    Manufacturer
    INVERNESS CORPORATION
    Product Code
    JYS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT REPORTED TO INVERNESS ON 11/13/2006. REQUESTED INFORMATION ON 11/27/2006, 12/12/2006 AND 01/03/2007. INFORMATION NOT RECEIVED UNTIL 06/19/2007.

    Description of Event or Problem · 1

    CONSUMER CLAIMS TO HAVE HAD EARS PIERCED WITH THE INVERNESS SYSTEM AT A RETAIL VENDOR IN 2006. SOUGHT MEDICAL ATTENTION FOR REDNESS AND SWELLING AT THE PIERCING SITE IN 2006. AN ORAL ANTIBIOTIC WAS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVERNESS EAR PIERCING SYSTEM EAR PIERCING INSTRUMENT JYS INVERNESS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other