BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 504511 · Received January 2, 2004

    Report

    Report Number
    2243569-2003-00020
    Event Type
    Other
    Date Received
    January 2, 2004
    Date of Event
    May 29, 2001
    Report Date
    December 30, 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 PIERECED WITH THE INVERNESS SYSTEM AT A RETAIL VENDOR IN 2001. SOUGHT MEDICAL ATTENTION FOR REDNESS AND SWELLING AT THE PIERCING SITE IN 11/01. AN ORAL ANTIBIOTIC WAS PRESCRIBED AT THAT TIME. RETURNED FOR TREATMENT IN 12/01 AND AN INCISION AND DRAINAGE WAS PERFORMED AND A NEW ORAL ANTIBIOTIC WAS PRESCRIBED. PATIENT RETURNED FOR INCISION AND DRAINAGE FIVE TIMES AND WAS PRESCRIBED A NEW ORAL ANTIBIOTIC.

    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 60 YR Other