BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 473338 · Received July 21, 2003

    Report

    Report Number
    2243569-2003-00010
    Event Type
    Other
    Date Received
    July 21, 2003
    Date of Event
    June 24, 2002
    Report Date
    July 17, 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. SOUGHT MEDICAL ATTENTION FOR REDNESS AND SWELLING AT THE PIERCING SITE 36 DAYS LATER. AT THIS TIME ORAL ANTIBIOTICS WERE PRESCRIBED 2 DAYS LATER. THEY RETURNED FOR MEDICAL ATTENTION AND AN INCISION AND DRAINAGE WAS PERFORMED AND ORAL ANTIBIOTICS WERE CONTINUED. 5 DAYS LATER, THEY SOUGHT MEDICAL ATTENTION FOR MORE SWELLING AT THE PIERCING SITE AND I.V. ANTIBIOTICS WERE ADMINISTERED AND A NEW ORAL ANTIBIOTICS WAS PRESCRIBED.

    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 26 YR Other