BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 1023714 · Received April 1, 2008

    Report

    Report Number
    1034548-2008-00004
    Event Type
    Other
    Date Received
    April 1, 2008
    Report Date
    March 4, 2008
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    PMA / PMN Number
    960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SOME INFO FOR THIS REPORT HAD NOT BEEN PROVIDED AT THIS FILING. IF THE INFO IS PROVIDED AT A LATER DATE, A SUPPLEMENTAL FILING WILL BE SENT. THE EVENT DESCRIPTION DOES NOT SUGGEST THAT THE FUNCTIONAL PERFORMANCE OF THE DEVICE WAS OUT OF SPECIFICATION. THE PRODUCT IS PROVIDED STERILE. STUDIES HAVE SHOWN THAT FOLLOWING APPLICATION OF DERMABOND, IT ACTS AS A BARRIER TO PREVENT MICROBIAL INFILTRATION INTO THE HEALING WOUND. INFECTION IS A POST-OPERATIVE COMPLICATION THAT CAN BE CAUSED BY A VARIETY OF FACTORS SUCH AS TYPE OF LACERATION, THE WOUND CLEANSING PROCEDURE, OR THE PT'S CONDITION BEFORE DEVICE APPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CALLER THAT THE PT HAD UNDERWENT A PACEMAKER IMPLANT APPROX ONE WEEK AGO. DERMABOND WAS USED TO CLOSE THE INCISION SITE. THE PT WAS SEEN IN THE OFFICE AND THE DR. OBSERVED SEVERE INDURATION, WEEPING DRAINAGE AND ENLARGEMENT OF THE AREA WHERE THE DERMABOND WAS PLACED. THE PT WAS SENT TO THE HOSP TO BE ADMITTED FOR FURTHER TREATMENT. THE CALLER STATED THAT THE WEEPING DRAINAGE THAT HE IS OBSERVING IS NOT WHAT HE WOULD EXPECT TO SEE WITH AN INFECTION. HE STATED THAT THE PT IS BEING HOSPITALIZED FOR TREATMENT OF POTENTIAL INFECTION BUT FEELS THAT THE AREA UNDER THE DERMABOND IS ACTUALLY BEGINNING TO EXPERIENCE NECROSIS. NO ADD'L INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMABOND TOPICAL SKIN ADHESIVE TISSUE ADHESIVE FOR SOFT TISSUE APPROX. MPN CLOSURE MEDICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O