BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 488897 · Received October 8, 2003

    Report

    Report Number
    2243569-2003-00014
    Event Type
    Other
    Date Received
    October 8, 2003
    Date of Event
    June 16, 2003
    Report Date
    October 7, 2003
    Manufacturer
    INVERNESS CORP.
    Product Code
    JYS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER CLAIMS TO HAVE HAD EARS PIERCED WITH THE INVERNESS SYSTEM AT A RETAIL VENDOR IN 2003. SOUGHT MEDICAL ATTENTION FOR REDNESS AND SWELLING AT THE PIERCING SITE IN 6/2003. AN INCISION AND DRAINAGE WAS PERFORMED AND ORAL ANTIBIOTICS WERE PRESCRIBED. RETURNED FOR MEDICAL TREATMENT IN 06/2003 AND ANOTHER INCISION AND DRAINAGE WAS PERFORMED AND I.V. ANTIBIOTICS WERE ADMINISTERED. PT WAS CONTINUED ON ORAL AND I.V. ANTIBIOTICS AT HOME FOR A PERIOD OF 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVERNESS EAR PIERCING SYSTEM EAR PIERCING INSTRUMENT AND EAR PIERCING EARRINGS JYS INVERNESS CORP. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other