BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 473672 · Received July 22, 2003

    Report

    Report Number
    2243569-2003-00011
    Event Type
    Other
    Date Received
    July 22, 2003
    Date of Event
    August 9, 2002
    Report Date
    July 21, 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 EAR PIERCED WITH THE INVERNESS EAR PIERCING SYSTEM AT A RETAIL VENDOR IN 02. SOUGHT MEDICAL ATTENTION FOR REDNESS AND SWELLING AT THE PIERCING SITE 4 DAYS LATER AND ORAL ANTIBIOTICS WERE PRESCRIBED. RETURNED FOR MEDICAL ATTENTION 6 DAYS LATER AND A NEW ORAL ANTIBIOTIC WAS PRESCRIBED AND AN INCISION AND DRAINAGE WAS PERFORMED. THE FOLLOWING DAY ANOTHER INCISION AND DRAINAGE WAS PERFORMED AND HOME CARE I.V. ANTIBIOTICS WERE PRESCRIBED. ONE WEEK LATER THEY WERE PRESCRIBED ANOTHER 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 16 YR Other