BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 491534 · Received October 16, 2003

    Report

    Report Number
    2243569-2003-00016
    Event Type
    Other
    Date Received
    October 16, 2003
    Date of Event
    December 27, 2002
    Report Date
    October 15, 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 EAR PIERCED WITH THE INVERNESS SYSTEM AT A RETAIL VENDOR IN 2002. SOUGHT MEDICAL ATTENTION FOR REDNESS AND SWELLING AT THE PIERCING SITE IN 01/03. AT THIS TIME CONSUMER WAS PRESCRIBED ORAL ANTIBIOTICS. IN 01/03 AN INCISION AND DRAINAGE WAS PERFORMED AND THE ANTIBIOTCS WERE CONTINUED. RETURNED FOR MEDICAL ATTENTION TWO DAYS LATER AND ANOTHER INCISION AND DRAINAGE WAS PERFORMED AND AN ANTIBIOTIC INJECTION WAS GIVEN. CONSUMER CONTINUED TO RECEIVE THE INJECTIONS DAILY FOR APPROXIMATELY 10 DAYS. IN 2/03 CONSUMER SOUGHT MEDICAL ATTENTION AGAIN AND ANOTHER INCISION AND DRAINAGE WAS PERFORMED AND HOME I.V. ANTIBIOTICS WERE PRESCRIBED. CONSUMER WAS PLACED ON A NEW ORAL ANTIBIOTIC AS WELL FOR TWO 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 16 YR Other