BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 371132 · Received January 10, 2002

    Report

    Report Number
    2243569-2002-00002
    Event Type
    Other
    Date Received
    January 10, 2002
    Date of Event
    June 17, 2000
    Report Date
    January 9, 2002
    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 PIERCED WITH THE INVERNESS EAR PIERCING SYSTEM AT A RETAIL VENDOR IN 2000. THE CONSUMER SOUGHT MEDICAL TREATMENT FOR AN INFECTION AT THE EAR PIERCING SITE 3 WEEKS LATER. AN INCISION AND DRAINAGE WAS PERFORMED AND THE CONSUMER WAS PLACED ON ORAL ANTIBIOTICS. SOUGHT MEDICAL TREATMENT AGAIN 4 WEEKS LATER AND AN INCISION AND DRAINAGE WAS PERFORMED. THE CONSUMER WAS ADMITTED TO THE HOSP THAT DAY AND RECEIVED I.V. ANTIBIOTICS. THE CONSUMER WAS DISCHARGED THE NEXT DAY AND WAS CONTINUED ON AN I.V. ANTIBIOTIC HOME TREATMENT.

    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 * *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other