BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 380297 · Received March 5, 2002

    Report

    Report Number
    1034548-2002-00017
    Event Type
    Other
    Date Received
    March 5, 2002
    Date of Event
    February 15, 2002
    Report Date
    March 4, 2002
    Manufacturer
    CLOSURE MEDICAL CORPORATION
    Product Code
    MPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE INFO SUPPLIED BY THE DISTRIBUTOR, IN 2002, THE PT WAS TREATED FACILITY FOR A LACERATION CROSS THE BRIDGE OF PT'S NOSE CAUSED BY HITTING HEAD ON A COFFEE TABLE. THE WOUND WAS IRRIGATED WITH SALINE, AND WIPED WITH A Q-TIP. NO FURTHER CLEANING OF THE SITE WAS PERFORMED. THE DERMABOND TOPICAL SKIN ADHESIVE WAS APPLIED TO THE WOUND. IT IS NOT CLEAR IF THE EDGES OF THE WOUND WERE APPROXIMATED PRIOR TO APPLICATION. THE WOUND WAS THEN COVERED WITH STERI-STRIPS, EXCEPT FOR ONE END OF THE WOUND. THE FAMILY MEMBER NOTED THAT THE UNCOVERED END OF THE WOUND RE-COMMENCED BLEEDING BEFORE FAMILY MEMBER AND THE PT LEFT THE EMERGENCY ROOM. THE NEXT DAY, THE PT DEVELOPED A FEVER OF 101.5. THE FAMILY MEMBER RETURNED THE PT TO THE EMERGENCY ROOM BECAUSE FAMILY MEMBER FELT THE WOUND MAY HAVE BECOME INFECTED. MD DID NOT EXAMINE THE WOUND AT THAT TIME. PT RETURNED HOME. THE FOLLOWING DAY, THE FEVER WENT UP TO 104, THE FAMILY MEMBER TOOK PT TO AN EMERGENCY ROOM IN ANOTHER CITY, WHERE THE PT RECEIVED TWO INJECTIONS OF ROCEPHIN, AND WAS STARTED ON ORAL KEFLEX, MD IN THAT EMERGENCY ROOM INDICATED THAT SHE BELIEVES THAT THE DERMABOND TOPICAL SKIN ADHESIVE WAS NOT USED PROPERLY, THAT THE WOUND WAS TOO DEEP FOR JUST APPLICATION OF DERMABOND. THE FAMILY MEMBER ASKED THE ORIGINAL EMERGENCY ROOM FACILITY TO REFER FAMILY MEMBER TO A PLASTIC SURGEON WHEN FAMILY MEMBER WAS THERE ON THE DAY OF THE EVENT. MD WOULDN'T REFER TO A PLASTIC SURGEON, HE SAID THAT ANY SCARRING WOULD BE MINIMAL. FAMILY MEMBER INDICATED THAT THE PLASTIC SURGEON FAMILY MEMBER CONSULTED EXAMINED THE WOUND 11 DAYS LATER AND STATED THAT THERE IS NO TREATMENT TO BE APPLIED AT THIS TIME WHEN WOUND HEALS COMPLETELY THEY WILL REACCESS THE NEED TO REVISE ANY SCARRING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention