BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 496035 · Received November 12, 2003

    Report

    Report Number
    2243569-2003-00017
    Event Type
    Other
    Date Received
    November 12, 2003
    Date of Event
    March 31, 2003
    Report Date
    November 10, 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 2003. SOUGHT MEDICAL ATTENTION TWO WEEKS LATER AND AN ORAL ANTIBIOTIC WAS PRESCRIBED. RETURNED FOR MEDICAL TREATMENT 3 DAYS LATER WHEN AN INCISION AND DRAINAGE WAS PERFORMED AND THE ORAL ANTIBIOTIC WAS CONTINUED. RETURNED AGAIN FOR TREATMENT WHEN ANOTHER INCISION AND DRAINAGE WAS PERFORMED AND I.V. ANTIBIOTICS WERE ADMINISTERED. CONSUMER WAS ADMITTED TO THE HOSPITAL. DURING HOSPITAL STAY RECIEVED ORAL ANTIBIOTICS, I.V. ANTIBIOTICS AND ANOTHER INCISION AND DRAINAGE WAS PERFORMED. WAS DISHCARGED ONE WK LATER AND WAS CONTINUED ON ORAL ANTIBIOTICS.

    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 45 YR Other