BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 478286 · Received August 14, 2003

    Report

    Report Number
    2243569-2003-00013
    Event Type
    Other
    Date Received
    August 14, 2003
    Date of Event
    December 2, 2001
    Report Date
    August 13, 2003
    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 EARS PIERCED WITH THE INVERNESS SYSTEM AT A RETAIL VENDOR IN 2001. SOUGHT MEDICAL ATTENTION FOR REDNESS AND SWELLING AT THE PIERCING SITE 8 DAYS LATER. PT WAS ADMITTED INTO THE HOSP AT THAT TIME AND ORAL ANTIBIOTICS WERE GIVEN, I.V. ANTIBIOTICS WERE ADMINISTERED AND AN INCISION AND DRAINAGE WAS PERFORMED. PT WAS CONTINUED ON THE ANTIBIOTICS AND ANOTHER INCISION AND DRAINAGE WAS PERFORMED 2 DAYS LATER. PT WAS DISCHARGED 3 DAYS LATER 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 JYS INVERNESS CORP NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other