BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANCHOR FIX UNDERWRAP

    MDR report key: 858669 · Received May 31, 2007

    Report

    Report Number
    2939821-2007-00001
    Event Type
    Other
    Date Received
    May 31, 2007
    Report Date
    May 25, 2007
    Manufacturer
    NORTH COAST MEDICAL, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUSLY, PROD INSTRUCTIONS WERE PLACED IN KITS THAT INCLUDED THIS ITEM. AS A CORRECTIVE ACTION, CAUTIONARY LABELS HAVE BEEN PLACED ON ALL STOCK FOR THIS ITEM, RECOMMENDING THE USE OF SKIN BARRIER WIPES TO HELP PREVENT SKIN IRRITATION. ATTEMPTED TO CONTACT CUSTOMER MULTIPLE TIMES SINCE COMPLAINT WAS FIRST MADE TO NORTH COAST MEDICAL. UNABLE TO GATHER ADEQUATE INFO UNTIL 5/23/07. DATES OF CONTACT TO USER OF PROD. ON 04/11/07;04/13/07;04/19/07 SPOKE TO REPORTER. ON 05/01/07; 05/07/07; 05/11/07 SPOKE TO USER. DID NOT KNOW USER. 05/11/07 VOICE MAIL FROM REPORTER. ON 05/23/07 SPOKE TO ANOTHER USER. REC'D INFO ABOUT EVENT.

    Description of Event or Problem · 1

    ALCOHOL WAS USED TO PREPARE PT'S SKIN. THERAPIST APPLIED ANCHOR FIX (ADHESIVE UNDERWRAP) TO PT'S SHOULDER. UPON REMOVAL OF ANCHOR FIX, SEVERAL SMALL PIECES OF SKIN WERE REMOVED FROM THE PT'S SHOULDER, CAUSING IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR FIX UNDERWRAP ADHESIVE FABRIC TAPE (UNDERWRAP) KGX NORTH COAST MEDICAL, INC. NC22001-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other