BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 474882 · Received July 28, 2003

    Report

    Report Number
    2243569-2003-00012
    Event Type
    Other
    Date Received
    July 28, 2003
    Date of Event
    June 25, 2002
    Report Date
    July 25, 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 2002. SOUGHT MEDICAL ATTENTION FOR REDNESS AND SWELLING AT THE PIERCING SITE 13 DAYS LATER AND ORAL ANTIBIOTICS WERE PRESCRIBED. RETURNED FOR MEDICAL TREATMENT ONE WEEK LATER AND AN INCISION AND DRAINAGE WAS PERFORMED AND ORAL ANTIBIOTICS WERE CONTINUED. A WEEK LATER ANOTHER INCISION AND DRAINAGE WAS PERFORMED. THE NEXT DAY, PT WAS STARTED ON A HOME I.V. ANTIBIOTIC THERAPY WHICH LASTED ONE WEEK. AFTER THAT WEEK, THE PT WAS PRESCRIBED A NEW ORAL ANTIBIOTIC.

    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 12 YR Other