BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 515496 · Received March 9, 2004

    Report

    Report Number
    2243569-2004-00001
    Event Type
    Other
    Date Received
    March 9, 2004
    Date of Event
    June 30, 2002
    Report Date
    March 8, 2004
    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 EAR PIERCING SYSTEM IN 2002. SOUGHT MEDICAL ATTENTION TWO WEEKS LATER FOR REDNESS AND SWELLING AT THE PIERCING SITE AND WAS PRESCRIBED ORAL ANTIBIOTICS. RETURNED FOR MEDICAL TREATMENT ELEVEN DAYS LATER AND AN INCISION AND DRAINAGE WAS PERFORMED. AT THAT TIME PT WAS SENT TO THE HOSP AND WAS ADMITTED. DURING THEIR HOSP STAY, ANOTHER INCISION AND DRAINAGE WAS PERFORMED, I.V. ANTIBIOTICS WERE ADMINISTERED, AND ORAL ANTIBIOTICS WERE GIVEN. PT WAS DISCHARGED IN 07/02 AND WAS CONTINUED ON ORAL ANTIBIOTICS.

    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 12 YR Other