BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMA+FLEX QS

    MDR report key: 3181982 · Received June 14, 2013

    Report

    Report Number
    3010034760-2013-00011
    Event Type
    Other
    Date Received
    June 14, 2013
    Report Date
    June 14, 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

    THIS COMPLAINT WAS RECEIVED FROM ONE CLINICIAN WHO WAS DISSATISFIED WITH PT OUTCOMES FOLLOWING GYNECOLOGICAL PROCEDURES. THE DEVICES WERE NOT RETURNED AND LOT NUMBERS WERE NOT PROVIDED. THE SALES REP COMMUNICATED WITH THE CLINICIAN DIRECTLY AND ADVISED ON PROPER ADHESIVE APPLICATION TECHNIQUE AND PT AFTER CARE INSTRUCTIONS. WOUND DEHISCENCE MAY OCCUR IF THE ADHESIVE IS APPLIED IMPROPERLY OR IF PTS DO NOT PROPERLY CARE FOR THEIR WOUNDS POST-OPERATIVELY. IN BOTH CASES SIGNIFICANT TRAINING IS INVOLVED TO MAKE SURE ERRORS DO NOT OCCUR. LABELING ALSO INDICATES PROPER APPLICATION AND CARE INSTRUCTIONS. DURING INVESTIGATION, CMPI INTERVIEWED (B)(6) AND NOTED THAT THE SURGEON DID NOT USE DEEP-DERMAL OR SUBCU SUTURES IN CONJUNCTION WITH THE ADHESIVE, AS IT IS INDICATED. IT IS POSSIBLE THAT THESE WOUNDS WERE UNDER HIGH TENSION AND WITHOUT SUTURES WERE VULNERABLE TO DEHISCENCE, ESPECIALLY IF PTS DID NOT FOLLOW PROPER AFTERCARE. CMPI HAS REQUESTED MORE INFORMATION TO HELP COMPLETE THIS INVESTIGATION. IF MORE INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DR. (B)(6) EXPRESSED CONCERNS REGARDING DERMA+FLEX QS AND OPEN WOUNDS ON 4 OUT OF 8 PTS WHO RETURNED TO ED POST OP. WOUNDS WERE SMALL, BUT OPEN. PROCEDURES WERE BOTH LAPAROSCOPIC AND TOTAL HYSTERECTOMIES. DOCTOR DID NOT USE DEEP DERMAL OR SUBCUTANEOUS SUTURES FOR ANY OF THESE CASES. NO SPECIFIC PT OR EVENT INFORMATION WAS PROVIDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270888 DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MPN CHEMENCE MEDICAL PRODUCTS, INC. QS70806 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other