BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMA+FLEX

    MDR report key: 1649240 · Received March 26, 2010

    Report

    Report Number
    1067168-2010-00001
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Date of Event
    October 26, 2009
    Report Date
    March 25, 2010
    Manufacturer
    CHEMENCE MEDICAL PRODUCTS INC.
    Product Code
    KMF
    PMA / PMN Number
    K050757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADVERSE EVENT NOTIFICATION FROM THE USER-FACILITY, THE FACILITY'S RISK MGR WAS CONTACTED. SHE WAS ASKED ABOUT CRUCIAL INFO NECESSARY IN ORDER TO PERFORM AN INVESTIGATION OF THE DEVICE, BUT SHE STATED THAT SHE DIDN'T KNOW AND WAS "GOING TO TRY TO REACH THE NURSE AND DOCTOR WHO PERFORMED THE SURGERY." (B)(6) DID NOT COME BACK TO US WITH ANY ADD'L INFO. THE INFO REQUESTED CONSISTED OF THE FOLLOWING: LOT NUMBER, EXACT DESCRIPTION OF HOW THE DR APPLIED THE ADHESIVE, WHEN DID THE PT FIRST NOTICE WOUND DEHISCENCE. WE MAINTAIN RETENTION SAMPLES OF ALL LOTS MANUFACTURED BUT IT WAS IMPOSSIBLE TO RUN ANY KIND OF TESTING WITHOUT KNOWING THE LOT NUMBER. AFTER READING THE EVENT, AS IT WAS DESCRIBED BY THE FACILITY'S REPORTER, A CONCLUSION WAS DRAWN BASED ON THE NARRATIVE FROM THE INITIAL REPORTER. IT WAS CONCLUDED BY US THAT THE USER OF THE DEVICE DID NOT USE THE ADHESIVE AS PER ITS INDICATIONS. SURE+CLOSE IS A CONVENIENCE KIT CONTAINING SURE+CLOSE WOUND CLOSURE STERILE STRIPS AND DERMA+FLEX. DERMA+FLEX IS A LIQUID BANDAGE INDICATED TO COVER MINOR CUTS, SCRAPES, MINOR SKIN IRRITATIONS. DERMA+FLEX MAY BE USED OVER WOUND CLOSURE STRIPS, SUTURES, STAPLES, ETC, BUT IT'S NOT A REPLACEMENT FOR ANY WOUND CLOSURE METHOD, THEREFORE, WE DO NOT RECOMMEND OR ADVERTISE THE USE OF DERMA+FLEX FOR THIS INDICATION. MOREOVER, CYANACRYLATE MEDICAL ADHESIVES ARE NOT RECOMMENDED TO BE USED IN MUCOSAL SURFACES. IT WAS CONCLUDED THAT THE USER DID NOT FOLLOW THE MFR'S INSTRUCTIONS FOR USE, ENCLOSED WITHIN THE DEVICE PACKAGE, AND MADE OFF-LABEL USE OF THE DEVICE. ADD'L INFO FROM THE 2ND REPORT: SURE CLOSE WOUND CLOSURE SYSTEM.

    Description of Event or Problem · 1

    ACCORDING TO THE USER FACILITY REPORTER, "THE PT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY, TRANSOBTURATOR SUBURETHRAL SLING, HIGH UTEROSACRAL VAULT SUSPENSION, ANTERIOR AND POSTERIOR COLPHORRHAPHY, AND CYSTOSCOPY. THE SUBURETHRAL SLING GROIN/PARALABIAL 1-1 1/2 CM INCISIONS WERE CLOSED WITH SURE CLOSE SKIN GLUE. DURING THE ONE WEEK F/U OFFICE VISIT, THE PT COMPLAINED OF "OPEN INCISION." GLUE ON THE RIGHT WAS NOTED TO HAVE FORMED A FIRM EDGE FROM APPROXIMATING. IT WAS REMOVED AND CLOSED SPONTANEOUSLY WITHIN FEW DAYS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMA+FLEX LIQUID BANDAGE KMF CHEMENCE MEDICAL PRODUCTS INC. CE 0086 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other