BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA NO-STING BARRIER FILM 3ML

    MDR report key: 3061994 · Received April 16, 2013

    Report

    Report Number
    3006760724-2013-00003
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 16, 2013
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    KMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IS IN PROGRESS, INVESTIGATION RESULTS AND ANY SUBESQUENT INFORMATION WILL BE PROVIDED IN A SUPPLEMENT REPORT.

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW HAS COMPLETED OUR INVESTIGATION INTO THIS EVENT. AFTER A THOROUGH INVESTIGATION WE HAVE CONCLUDED THAT A DEVICE FAILURE OR PRODUCT DEFICIENCY DID NOT CAUSE OR CONTRIBUTE TO THE EVENTS REPORTED. THE COMPLAINT REPORTED IS RELATED TO LACK OF KNOWLEDGE WITH THE PRODUCT AND ITS HIGH FLAMMABILITY. SECURA NO-STING BARRIER FILM IS A HEXAMETHYLDISILOXANE, ACRYLATE COPOLYMER PRODUCT AND INTENDED FOR USE AS A FILM-FORMING PRODUCT WHICH UPON APPLICATION TO INTACT OR DAMAGED SKIN FORMS A LONG LASTING WATERPROOF BARRIER. THE SECURA NO-STING BARRIER FILM PRODUCT INSERT CONTAINS DETAILED WARNINGS ABOUT AVOIDING PRODUCT USE AROUND FLAMES AND SOURCES OF IGNITION. THE PRODUCT LABELING ALSO DISPLAYS AN ORANGE COLOR FLAMMABLE SYMBOL. THE ROOT CAUSE OF THIS ISSUE IS INCORRECT PRODUCT USE AND IMPROPER USE OF THE PRODUCT BY THE HEALTHCARE PRACTITIONER. THE INITIAL REPORT INDICATED THAT THE SECURA NO-STING BARRIER FILM WAS USED WAS USED WITH A NEGATIVE PRESSURE WOUND THERAPY KIT. THE KIT CONTAINS A SECURA NO-STING BARRIER FILM WIPE PACKET OF THE SAME FORMULATION, AND IN THIS CASE THE HEALTHCARE PRACTITIONER ALSO USED ADDITIONAL PRODUCT IN THE FORM OF A SECURA NO-STING BARRIER FILM 3ML SWAB. BOTH THE WIPE AND THE SWAB LABELING DISPLAY THE SAME FLAMMABLE WARNING. AS AN ADDED PRECAUTION, AND TO ENSURE THE CONTINUED SAFE USE OF OUR PRODUCTS THE INSTRUCTIONS FOR USE FOR THE NEGATIVE PRESSURE KIT WILL BE REVISED TO INCLUDE THE SAME WARNINGS AS THE WIPES/SWAB PRODUCTS. NO FURTHER INVESTIGATION OR CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME. SMITH & NEPHEW WILL CONTINUE TO MONITOR THE COMPLAINT SYSTEM, AND OTHER POST-MARKET SURVEILLANCE SYSTEMS FOR ANY RELATED INCIDENTS, OR SIGNIFICANT TRENDS OF THIS TYPE.

    Description of Event or Problem · 1

    NURSE OPENED THE SECURA NO-STING BARRIER FILM AND SOME OF THE LIQUID SPLASHED TO THE FLOOR AND THE NURSE'S COAT. PRACTITIONER APPLIED SECURA NO-STING BARRIER FILM TO THE PERIWOUND AREA OF THE PATIENT. SURGEON NOTICED A BLEED, AND PRIOR TO ALLOWING THE SECURA NO-STING BARRIER FILM TO DRY COMPLETELY, THE SURGEON USED A CAUTERIZATION DEVICE TO SEAL THE BLEED. THE CAUTERIZATION DEVICE CAUSED THE AREA EXPOSED TO THE SECURA NO-STING BARRIER FILM, AS WELL AS NURSE'S GOWN TO IGNITE. PATIENT SUFFERED 2ND DEGREE BURNS APPROXIMATELY 10CM AROUND THE TREATED AREA. NO HARM TO THE NURSE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163449 SECURA NO-STING BARRIER FILM 3ML BANDAGE, LIQUID KMF SMITH & NEPHEW WOUND MANAGEMENT 66800711 0868

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R