BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 229679 · Received June 22, 1999

    Report

    Report Number
    2243569-1999-00028
    Event Type
    Other
    Date Received
    June 22, 1999
    Date of Event
    March 17, 1999
    Report Date
    June 22, 1999
    Manufacturer
    INVERNESS CORP.
    Product Code
    JXS
    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 ON 3/17/99. A FEW DAYS LATER HER EAR WAS GETTING RED SO SHE TRIED TO REMOVE THE EARRING CAUSING IT TO BECOME EMBEDDED IN HER EAR. SHE SOUGHT MEDICAL TREATMENT FOR REMOVAL AND WAS PRESCRIBED AN ANTIBIOTIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other