BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 675837 · Received February 13, 2006

    Report

    Report Number
    2243569-2006-00001
    Event Type
    Other
    Date Received
    February 13, 2006
    Date of Event
    December 27, 2003
    Report Date
    February 8, 2006
    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 HAD HIS EARS PIERCED AT A RETAIL VENDOR WITH THE INVERNESS SYSTEM IN 2003. SOUGHT MEDICAL ATTENTION FOR REDNESS AND SWELLING AT THE PIERCING SITE IN 01/2004. ORAL ANTIBIOTICS WERE PRESCRIBED AT THAT TIME. SOUGHT MEDICAL ATTENTION AGAIN IN 01/2004 AND WAS ADMITTED TO THE HOSPITAL AT THAT TIME IN 01/2004 AN INCISION AND DRAINAGE WAS PERFORMED AND I.V. ANTIBIOTICS WERE ADMINISTERED. A REPEAT INCISON AND DRAINAGE WAS PERFORMED FOUR DAYS LATER AND I.V. ANTIBIOTICS WERE CONTINUED. SHE WAS DISCHARGED, AFTER THREE DAYS AND ORAL ANTIBIOTICS WERE PRESCRIBED.

    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. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other