BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIGH-PULL HEADCAP

    MDR report key: 21627 · Received April 25, 1995

    Report

    Report Number
    2018192-1995-00001
    Event Type
    Injury
    Date Received
    April 25, 1995
    Date of Event
    February 3, 1995
    Report Date
    March 29, 1995
    Manufacturer
    HOOD-GEAR PACIFIC, INC.
    Product Code
    DZB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FEMALE PT WAS PRESCRIBED AND FITTED WITH A "HIGH-PULL HEADCAP" IN LATE 12/94. DURING AN APPOINTMENT WITH DENTIST ON 2/3/95, HE OBSERVED ABRASIONS ON BOTH OF THE PTS' EARS, PURPORTEDLY CAUSED BY STRAPS ON THE DEVICE. THE DEVICE WAS REMOVED BY DENTIST. THE PT SUBSEQUENTLY CONTRACTED A STAPYLOCOCCUS INFECTION, POSSIBLE AT THE ABRASION SITES. THE PT SOUGHT AND RECEIVED TREATMENT FROM A PHYSICIAN AND A DERMATOLOGIST. AT THIS TIME, PT'S ABRASIONS HAVE HEALED. ON 5/29/95, ALL HIGH PULL HEADGEAR WITH THE SAME DESIGN AS THE PRODUCT USED BY THE PT IN QUESTION WHICH HE HAD IN INVENTORY WAS QUARANTINED FOR SHIPMENT BACK TO THE SUPPLIER. A NEW DESIGN WHICH ELIMINATES THE SUSPECTED PROBLEM SITE ON THE HEADGEAR HAS BEEN SUBSTITUTED FOR THE ORIGINAL INVENTORY AND WILL BE SHIPPED WTH ALL FUTURE ORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH-PULL HEADCAP ORTHODONTIC HEADGEAR DZB HOOD-GEAR PACIFIC, INC. 016-000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention