BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMA AND FLEX QS

    MDR report key: 3108946 · Received May 6, 2013

    Report

    Report Number
    3010034760-2013-00009
    Event Type
    Other
    Date Received
    May 6, 2013
    Date of Event
    February 27, 2012
    Report Date
    May 6, 2013
    Manufacturer
    CHEMENCE MEDICAL PRODUCTS INC.
    Product Code
    MPN
    PMA / PMN Number
    K101276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER INFORMATION WAS PROVIDED, HOWEVER A DETAILED INVESTIGATION COULD NOT BE COMPLETED FOR SPECIFIC INCIDENTS BECAUSE WE RECEIVED TWO LOT NUMBERS. THERE WAS NO DETAILED INFORMATION PROVIDED ON THE SPECIFIC INCIDENT, ABOUT THE SPECIFIC PATIENT OR FOLLOW UP CARE. THE BATCH RECORDS WERE REVIEWED AND NO DEVIATIONS WERE FOUND THAT WOULD LEAD CMPI TO BELIEVE THE PRODUCT WAS MANUFACTURED INCORRECTLY. THE SALES REP PROVIDED PHOTOGRAPHS OF INCISIONS WHICH WERE PART OF CARDIAC CABG PROCEDURES. THE PHOTOGRAPHS INDICATE LONG INCISIONS IN POTENTIALLY HIGH STRESS AREAS THAT WERE CLOSED WITH GLUE ONLY SHOWING EVIDENCE OF WOUND DEHISCENCE. LONG INCISIONS IN HIGH STRESS AREAS OF BODY MAY REQUIRE THE APPLICATION OF SUTURES OR STERI-STRIPS TO AID IN WOUND APPROXIMATION WHEN CLOSING INCISIONS USING TOPICAL TISSUE ADHESIVE. THE DEVICE WAS NOT RETURNED NOR IS THERE ANY ADDITIONAL INFORMATION AVAILABLE TO ENABLE A MORE DETAILED INVESTIGATION. ALTHOUGH THE DISTRIBUTOR REPORTED THAT THE ROOT CAUSE COULD NOT BE DETERMINED IN THIS CASE, IMPROPER APPLICATION TECHNIQUE (NOT ENOUGH ADHESIVE) OR POOR POST-OP CARE OF THE WOUND COULD POSSIBLY LEAD TO PREMATURE WOUND DEHISCENCE.

    Description of Event or Problem · 1

    A DISSATISFIED CARDIAC SURGEON REPORTED THEY WERE HAVING TROUBLE WITH WOUNDS OPENING POST OP (DAY 3) AFTER USING ADHESIVE TO CLOSE INCISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197387 DERMA AND FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MPN CHEMENCE MEDICAL PRODUCTS INC. QS70806 12M0303Q1-01 AND Q3

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other