BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEO LOOP

    MDR report key: 883029 · Received July 18, 2007

    Report

    Report Number
    2939821-2007-00002
    Event Type
    Other
    Date Received
    July 18, 2007
    Date of Event
    June 7, 2007
    Report Date
    July 17, 2007
    Manufacturer
    NORTH COAST MEDICAL, INC.
    Product Code
    FZF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO OBTAIN INFORMATION FROM HOSPITAL AND CLINIC. UNUSED MATERIAL FROM USER TO BE RETURNED TO MANUFACTURER FOR TESTING OF STAPHYLOCOCCUS AUREUS BACTERIA.

    Description of Event or Problem · 1

    HE CALLED ON 7/13/2007. HE SAID, HIS WIFE HAD A REACTION TO A STRAP USED ON AN AFO ANKLE AND FOOT ORTHOTIC. HE SAID, THE STRAPS WERE REPLACED ONE MONTH EARLIER, AND TWO DAYS LATER HIS WIFE HAD AN IRRITATION THAT HE SAYS REQUIRED 6 DAYS OF HOSPITALIZATION. AT THAT TIME, HE STATED HIS WIFE CONTRACTED A STAPH INFECTION (STAPHYLOCOCCUS AUREUS BACTERIA). HUSBAND STATES THIS RESULTED IN A PERMANENT SCAR. ONE MONTH LATER, THE STRAP WAS REPLACED AND THE AFO ORTHOTIC WAS DISINFECTED. (THE DATES WERE VERIFIED WITH FINGER LAKES PROSTHETICS AND ORTHOTICS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEO LOOP SPLINT STRAPPING FZF NORTH COAST MEDICAL, INC. NC15760 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| O