BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 499790 · Received December 5, 2003

    Report

    Report Number
    2243569-2003-00019
    Event Type
    Other
    Date Received
    December 5, 2003
    Date of Event
    July 19, 2003
    Report Date
    December 4, 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. THEY SOUGHT MEDICAL ATTENTION FOR REDNESS AND SWELLING AT THE PIERCING SITE 12 DAYS LATER. AT THAT TIME AN INCISION AND DRAINAGE WAS PERFORMED AND ORAL ANTIBIOTICS WERE PRESCRIBED. THEY RETURNED FOR TREATMENT THE NEXT DAY AND WAS ADMITTED TO THE HOSPTIAL. DURING THEIR STAY I.V. ANTIBIOTICS WERE ADMINISTERED AND AN INCISION AND DRAINAGE WAS PERFORMED. THEY WERE RELEASED FROM THE HOSPITAL 4 DAYS LATER AND WERE CONTINUED ON ORAL ANTIBIOTICS AND I.V. HOME THERAPY 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 12 YR Other