BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 309076 · Received December 14, 2000

    Report

    Report Number
    2243569-2000-00064
    Event Type
    Other
    Date Received
    December 14, 2000
    Date of Event
    June 22, 2000
    Report Date
    December 13, 2000
    Manufacturer
    *
    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. IMMEDIATELY AFTER CONSUMER WENT SWIMMING IN A LAKE. SHORTLY AFTER THE CONSUMER'S EAR SWELLED AND BECAME INFECTED. OVER A 2-3 WEEK PERIOD THE CONSUMER SAW TWO DOCTORS THAT DRAINED THE ABSCESS AND PLACED THE CONSUMER ON ANTIBIOTICS. THE CONSUMER SAW ANOTHER DR IN 2000 AND WAS PLACED IN THE HOSP FOR INCISION AND DRAINAGE OF THE SITE AND WAS PLACED ON A COURSE OF IV AND ORAL ANTIBIOTICS. THE CONSUMER WAS RELEASED IN 2000. THE CONSUMER WAS ADMITTED AGAIN IN 2000 FOR ANOTHER ABCESS WHICH WAS DRAINED AND IV ANTIBIOTICS WERE AGAIN GIVEN. THE CONSUMER WAS RELEASED WITH CONTINUED MEDICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other