BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 315405 · Received February 8, 2001

    Report

    Report Number
    2243569-2001-00007
    Event Type
    Other
    Date Received
    February 8, 2001
    Date of Event
    February 27, 2000
    Report Date
    February 8, 2001
    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 BEEN PIERCED WITH THE INVERNESS EAR PIERCING SYSTEM AT A RETAIL VENDOR IN 2000. IN 9 DAYS THE CONSUMER SOUGHT MEDICAL TREATMENT FOR A MASS ON THE EAR. IT WAS INCISED AND DRAINED AND WAS GIVEN AN ANTIBIOTIC. THE CONSUMER RETURNED TWO MORE TIMES WITH NO RELIEF AND THE ANTIBIOTIC WAS CHANGED. ABOUT 14 DAYS AFTER THE CONSUMER HAD SAME DAY SURGERY TO DRAIN AND REPAIR THE ABCESS AND WAS AGAIN PLACED ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4733 INVERNESS EAR PIERCING SYSTEM EAR PIERCING INSTRUMENT AND EAR PIERCING EARRINGS JYS INVERNESS CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other