BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND-AID BRAND PLUS ANTIBIOTIC

    MDR report key: 1304640 · Received February 3, 2009

    Report

    Report Number
    8041154-2009-00001
    Event Type
    Injury
    Date Received
    February 3, 2009
    Date of Event
    July 16, 2008
    Report Date
    February 3, 2009
    Manufacturer
    JOHNSON & JOHNSON INDUSTRIAL LTDA
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF SUMMARY DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY REVEALED NO ADVERSE TRENDS. THIS REPORT IS CONSIDERED CLOSED UNLESS ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    INITIALLY THIS WAS NOT REPORTED. MEDICAL REVIEWER THOUGHT THE CONSUMER EXPERIENCED CONTACT DERMATITIS BASED ON SHORT LENGTH OF TIME BETWEEN USE OF DEVICE AND ONSET OF SYMPTOMS. FOLLOW-UP REPORT REVEALED CONSUMER HAD A SMALL RED DOT ON HER FINGER AND APPLIED PRODUCT TO MIDDLE FINGER OF RIGHT HAND. FINGER BECAME PURPLE 15 MINUTES LATER. FINGER HAD BURNING SENSATION AND SWELLED. TWO DAYS LATER, ENTIRE HAND WAS PURPLE AND SWOLLEN. CONSUMER WENT TO THE EMERGENCY ROOM AND ER DIAGNOSIS WAS FINGER CELLULITIS AND ABSCESS. TREATMENT PLAN INCLUDED A RIGHT HAND X-RAY, INTRAVENOUS CLINDAMYCIN, ORAL BACTRIM DS, DILAUDID FOR PAIN AND ZOFRAN (BOTH WERE REFUSED), INCISION AND DRAINAGE, HAND SPLINT AND HAND SURGERY CONSULTATION. CONSUMER WAS NOT ADMITTED TO HOSPITAL. X-RAY REVEALED OLD FRACTURE OF ULNAR STYLOID AND SOFT TISSUE SWELLING OF INVOLVING 3RD DIGIT; NO FRACTURE OR OSTEOMYELITIS. THERE WAS NO INFORMATION FROM THE HAND SURGERY CONSULT. CONSUMER DEVELOPED A CELLULITIS AND ABSCESS OF THE RIGHT MIDDLE FINGER THAT REQUIRED MINOR SURGERY AND ANTIBIOTICS. MEDICAL REVIEWER CONCLUDED THAT THE CONSUMER HAD AN INFECTION OF THE FINGER AT THE TIME OF PRODUCT USE, AND THE INFECTION WORSENED TO THE POINT WHERE THE CONSUMER SOUGHT MEDICAL TREATMENT. THIS EVENT HAD A TEMPORAL (NOT CAUSAL) ASSOCIATION WITH THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAND-AID BRAND PLUS ANTIBIOTIC KGX - ADHESIVE BANDAGE KGX JOHNSON & JOHNSON INDUSTRIAL LTDA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other