BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVERNESS EAR PIERCING SYSTEM

    MDR report key: 293451 · Received August 22, 2000

    Report

    Report Number
    2243569-2000-00042
    Event Type
    Other
    Date Received
    August 22, 2000
    Date of Event
    December 20, 1999
    Report Date
    August 22, 2000
    Manufacturer
    INVERNESS CORPORATION
    Product Code
    JYS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    CONSUMER CLAIMS TO HAVE BEEN PIERCED WITH THE INVERNESS EAR PIERCING SYSTEM IN 1999 AT A RETAIL VENDOR. CONSUMER SOUGHT MEDICAL TREATMENT THAT SAME DAY FOR EAR PAIN. CONSUMER WAS PRESCRIBED ANTIBIOTIC WHICH CONSUMER DID NOT TAKE. CONSUMER SAW CONSUMER'S REGULAR DR AND WAS GIVEN A DIFFERENT ANTIBIOTIC. IN 2000 CONSUMER WAS ADMITTED INTO THE HOSP FOR INCISION AND DRAINAGE OF THE SITE 2 DAYS LATER AND WAS ADMINISTERED IV ANTIBIOTICS. CONSUMER WAS RELEASED ON 1/26/00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVERNESS EAR PIERCING SYSTEM EAR PIERCING INSTRUMENT & EAR PIERCING EARRINGS JYS INVERNESS CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other