BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 382519 · Received March 15, 2002

    Report

    Report Number
    2243569-2002-00003
    Event Type
    Other
    Date Received
    March 15, 2002
    Date of Event
    November 24, 2000
    Report Date
    March 14, 2002
    Manufacturer
    INVERNESS CORPORATION
    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. THIRTEEN DAYS LATER, CONSUMER SOUGHT MEDICAL TREATMENT FOR INFECTION AT THE PIERCING SITE WHERE AN INCISION AND DRAINAGE WAS PERFORMED AND ORAL ANTIBIOTICS WERE PRESCRIBED. SOUGHT MEDICAL TREATMENT AGAIN AT A LATER DATE AND WAS PLACED ON ANOTHER ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVERNESS EAR PIERCING SYSTEM EAR PIERCING INSTRUMENT & EAR PERCING EARRINGS JYS INVERNESS CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other