BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 515528 · Received March 9, 2004

    Report

    Report Number
    2243569-2004-00002
    Event Type
    Other
    Date Received
    March 9, 2004
    Date of Event
    November 19, 2003
    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 2003. PT SOUGHT MEDICAL ATTENTION FOR REDNESS AND SWELLING AT THE PIERCING SITE ELEVEN DAYS LATER AND AN INCISION AND DRAINAGE WAS PERFORMED AND ORAL ANTIBIOTICS WERE PRESCRIBED. RETURNED FOR MEDICAL TREATMENT EIGHT DAYS LATER. AN INCISION AND DRAINAGE WAS PERFORMED. PT WAS THEN TRANSFERRED TO THE HOSP AND WAS ADMITTED. DURING THEIR HOSPITAL STAY, ANOTHER INCISION AND DRAINAGE WAS PERFORMED AND I.V. ANTIBIOTICS WERE ADMINISTERED. PT WAS DISCHARGED IN 12/2003 AND WAS CONTINUED ON HOME I.V. ANTIBIOTICS FOR 3 WEEKS.

    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 11 YR Other