BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOUND BENZOIN TINCTURE

    MDR report key: 1612561 · Received February 15, 2010

    Report

    Report Number
    2110898-2010-00018
    Event Type
    Injury
    Date Received
    February 15, 2010
    Date of Event
    February 9, 2010
    Report Date
    February 10, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    KOY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT LABELING STATES THE EXPECTED AES WITH PRODUCT USE IN THE WARNING AND CONTRAINDICATION SECTIONS SHOWN BELOW. CONTRAINDICATIONS: STERI-STRIP COMPOUND BENZOIN TINCTURE SHOULD NOT BE USED ON PATIENTS WITH A PREVIOUS HISTORY OF COMPOUND BENZOIN TINCTURE. WARNINGS: ALLERGIC CONTACT DERMATITIS TO COMPOUND BENZOIN TINCTURE HAS BEEN REPORTED. FLAMMABLE. FOR EXTERNAL USE ONLY.

    Description of Event or Problem · 1

    PATIENT (WHO IS A NURSE) REPORTED DEVELOPING 2 BIG BLISTERS AND MANY, RAISED, RED, SMALLER BLISTER COVERING THE ENTIRE AREA UNDER THE STRIPS AND BEYOND, FOLLOWING WRIST SURGERY. COMPOUND BENZOIN TINCTURE WAS USED WITH THE STERI-STRIPS. PATIENT WAS TREATED WITH SILVADENE AND 2 DOSES OF LEVAQUIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOUND BENZOIN TINCTURE NA KOY 3M HEALTH CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention COMPOUND BENZOIN TINCTURE WAS USED UNDER| STERI-STRIP (B) (4) AS AN ADHESIVE ADJUNCT.