BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 491715 · Received October 16, 2003

    Report

    Report Number
    2243569-2003-00015
    Event Type
    Other
    Date Received
    October 16, 2003
    Date of Event
    February 6, 2001
    Report Date
    October 14, 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 2001. SOUGHT MEDICAL ATTENTION FOR REDNESS AND SWELLING AT THE PIERCING SITE IN 2/01. ORAL ANTIBIOTICS WERE PRESCRIBED. RETURNED FOR MEDICAL TREATMENT THREE DAYS LATER AND AN INCISION AND DRAINAGE WAS PERFORMED. TWO DAYS AFTER, AN INCISION AND DRAINAGE WAS PERFORMED AND A DOSE OF I.V. ANTIBIOTICS WAS ADMINISTERED. THE FOLLOWING DAY, PATIENT RETURNED FOR MEDICAL ATTENTION AND WAS ADMITTED INTO THE HOSPITAL. DURING PATIENT'S STAY, PATIENT WAS GIVEN I.V. ANTIBIOTICS AND ANOTHER INCISION AND DRAINAGE WAS PERFORMED. PATIENT WAS DISCHARGED FIVE DAYS AFTER ADMISSION AND WAS INSTRUCTED TO CONTINUE 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 18 YR Other