BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 1082945 · Received July 23, 2008

    Report

    Report Number
    1034548-2008-00020
    Event Type
    Other
    Date Received
    July 23, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 25, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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 SPEC, BUT DOES INDICATE A POSSIBLE SENSITIVITY REACTION TO CYANOACRYLATES OR IT'S DERIVATIVES. THE PACKAGE INSERT PROVIDES CONTRAINDICATIONS AND ADVERSE REACTIONS: DO NOT USE ON PTS WITH A KNOWN HYPERSENSITIVITY TO CYANOACRYLATES OR FORMALDEHYDE. REACTIONS MAY OCCUR IN PTS WHO ARE HYPERSENSITIVE TO CYANOACRYLATES OR FORMALDEHYDE.

    Description of Event or Problem · 1

    A SALES REP CALLED TO REPORT THAT THE DR USES DERMABOND OFTEN. THE DR USED DERMABOND ON A PT THAT HAD A LAPAROSCOPIC HYSTERECTOMY. THE PT HAD 3 TROCAR SITES WHERE DERMABOND WAS APPLIED AND THE PT RETURNED ONE WEEK POST OPERATIVELY EXHIBITING OOZING AND BLISTERS. THAT WAS APPROX 5 WEEKS AGO. THE BLISTERS HAD SPREAD TO HER LEG. THEY CULTURED IT AND IT WAS NEGATIVE FOR MRSA. DURING A F/U IN 2008, THE DR STATED THAT THE PT HAD SURGERY THE PREVIOUS MONTH, AND RETURNED THE FOLLOWING WEEK WITH A RASH WHICH ORIGINALLY STARTED AT THE INCISION SITES AND APPEARED AS A RED RASH. SINCE THEN, THE RASH BECAME WORSE AND SPREAD TO HER LOWER EXTREMITIES. SHE PRESCRIBED MULTIPLE ANTIBIOTICS SUCH AS AMOXICILLIN AND AN ANTIBIOTIC FOR MRSA. THE DR PRESCRIBED STEROID CREAMS AND HYDROCORTISONE FOR THE ITCHING. THE DR DOES NOT KNOW IF THE PT HAS ANY ALLERGIES.

    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 Other