BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 329294 · Received April 26, 2001

    Report

    Report Number
    2243569-2001-00016
    Event Type
    Other
    Date Received
    April 26, 2001
    Date of Event
    February 3, 2001
    Report Date
    April 26, 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 2001. 13 DAYS LATER CONSUMER SOUGHT MEDICAL TREATMENT FOR INFECTION OF ONE EARLOBE AND WAS PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19198 INVERNESS EAR PIERCING SYSTEM EAR PIERCING INSTRUMENT AND EAR PIERCING EARRINGS JYS INVERNESS CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other