BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 1112184 · Received August 6, 2008

    Report

    Report Number
    1034548-2008-00022
    Event Type
    Other
    Date Received
    August 6, 2008
    Date of Event
    May 19, 2008
    Report Date
    July 8, 2008
    Manufacturer
    CLOSURE MEDICAL CORPORATION
    Product Code
    MPN
    PMA / PMN Number
    960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SOME INFORMATION FOR THIS REPORT HAD NOT BEEN PROVIDED AT THIS FILING. IF THE INFORMATION 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, BUT DOES INDICATE A POSSIBLE SENSITIVITY REACTION TO CYANOACRYLATES OR ITS DERIVATIVES. THE PACKAGE INSERT PROVIDES CONTRAINDICATIONS AND ADVERSE REACTIONS: DO NOT USE ON PATIENTS WITH A KNOWN HYPERSENSITIVITY TO CYANOACRYLATES OR FORMALDEHYDE, REACTIONS MAY OCCUR IN PATIENTS WHO ARE HYPERSENSITIVE TO CYANOACRYLATES OR FORMALDEHYDE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE HAS HAD A RASH SINCE A WEEK POST OP FROM A SURGERY 7 WEEKS AGO. SHE HAS BEEN ITCHING SINCE THE SURGERY. SHE HAS BEEN ON STEROIDS INTERMEDIATELY FOR THREE WEEKS, HER RASH IS COVERING HER ENTIRE BODY WITH THE EXCEPTION OF FACE AND FEET. SHE STATES THAT THE SURGEON NOTED THAT HE USED DERMABOND ON THE INCISION AND INSIDE OF THE INCISION. DURING A FOLLOW UP IN 2008, THE CUSTOMER REPORTED THAT THE ITCHING BEGAN IMMEDIATELY AFTER SURGERY. A BATTERY PACK FOR A SPINAL PROCEDURE WAS PLACED IN THE LEFT HIP. DERMABOND WAS PLACED OVER THE ENTIRE HIP. RASH STARTED 4-5 DAYS LATER AND SPREAD FROM HIPS TO STOMACH. THE RASH WAS OVER ENTIRE BODY 5-6 DAYS POST OP, REPORTED AS PAINFUL. CUSTOMER WENT TO SURGEON WHO PLACED HER ON ZYRTEC. CUSTOMER WENT TO THE FAMILY DR. AND RECEIVED A SHOT OF CORTISONE WITH A PRESCRIPTION FOR PREDNISONE AND ATARAX FOR THREE WEEKS. DERMABOND WAS REMOVED ONE WEEK FROM SURGERY. NO DERMABOND PRESENT SINCE 2-3 WEEKS POST OP. PHYSICIAN OPINES SOME DERMABOND RAN INTERNAL TO THE INCISION AND THIS WAS THE SOURCE. CUSTOMER REPORTS THAT IF SHE IS ALLERGIC TO DERMABOND THE SURGEON WILL REOPERATE TO IRRIGATE THE WOUND AND DETERMINE IF ANY RESIDUAL DERMABOND (R) IS PRESENT.

    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 CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other