BEUDAMED
    FDA Adverse Event Other Summary report: N

    WESTERN FAMILY FABRIC ANTIBACTERIAL XL 8 CT.

    MDR report key: 2559990 · Received April 27, 2012

    Report

    Report Number
    1038758-2011-00001
    Event Type
    Other
    Date Received
    April 27, 2012
    Report Date
    March 14, 2011
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES OF THE ANTIBACTERIAL 0.1% BENZALKONIUM CHLORIDE PAD WAS TESTED BY THE PRODUCT SUPPLIER. THE PRODUCT MEETS THE SPEC REQUIREMENTS.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT HE UTILIZED THREE OF THE FABRIC ANTIBACTERIAL XL BANDAGES AT THE RATE OF ONE PER DAY, CHANGING AFTER TAKING A SHOWER, ON A CUT ON HIS LEFT SHIN AREA. AFTER 3 DAYS, HE NOTED THAT HIS LEG HAD TURNED DARK BROWN/RED IN THE AREA WHERE THE PAD OF THESE BANDAGES CONTACTED HIS LEG. PT REPORTED THAT HE CEASED USING THESE BANDAGES IMMEDIATELY. HE ALSO REPORTED THAT HE BEGAN TO EXPERIENCE OUTBREAKS OF WHAT COULD BE TERMED MASS SPORADIC ITCHING ON BOTH OF HIS LEGS, ARMS, STOMACH, AND CHEST AREAS. A RASH DEVELOPED AND BLEEDING BROKE OUT IN THESE AREAS. HE ALSO REPORTED THAT HE EXPERIENCED SHORTNESS OF BREATH AND WENT TO HIS LOCAL URGENT CARE PHYSICIAN. HE STATED THAT HE WAS PRESCRIBED PREDNISONE 20MG AND DIPHENHYDRAMINE HCL 25MG AND HIS PHYSICIAN STRONGLY ADVISED THAT IF HE DID NOT IMPROVE IN THE FOLLOWING 24 HOURS, TO RETURN FOR ADD'L TREATMENT IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WESTERN FAMILY FABRIC ANTIBACTERIAL XL 8 CT. FABRIC ANTIBACTERIAL BANDAGES KGX ASO LLC WEF4954-072-000 250690

    Patients

    Seq Age Sex Outcome Treatment
    1