BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 1736655 · Received June 25, 2010

    Report

    Report Number
    1063481-2010-00015
    Event Type
    Injury
    Date Received
    June 25, 2010
    Report Date
    June 25, 2010
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P010003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THE PATIENT UNDERWENT ENDOSCOPIC BROWLIFT, BLEPHAROPLASTY, AND CO2 LASER SKIN RESURFACING. BIOGLUE WAS USED FOR BROW FIXATION. SOME TIME AFTER SURGERY, THE PATIENT NOTICED TWO NODULES WHICH POSSIBLY COINCIDED WITH THE AREAS OF BIOGLUE APPLICATION. THE PATIENT HAS SINCE RECEIVED KENALOG INJECTIONS AND THE NODULES HAVE DECREASED IN SIZE. ONE NODULE IS COMPLETELY RESOLVED AND THE OTHER IS 75% RESOLVED. A REVIEW OF MANUFACTURING RECORDS HAS BEEN PERFORMED AND DEMONSTRATES THAT THE LOT MET ALL SPECIFICATIONS. A REVIEW OF THE AVAILABLE INFORMATION INDICATES THAT THE PATIENT MAY HAVE EXPERIENCED A FOREIGN BODY INFLAMMATORY REACTION TO BIOGLUE OR ANOTHER IMPLANT MATERIAL. HOWEVER, NO SPECIFIC CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED NODULES. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE PATIENT UNDERWENT A BROWLIFT PROCEDURE AND C02 LASER SKIN RESURFACING. BIOGLUE SURGICAL ADHESIVE WAS USED FOR BROW FIXATION. FOLLOWING THE SURGERY, TWO "NODULES" WERE OBSERVED ON THE FOREHEAD. HOWEVER, THE DATE THE NODULES WERE FIRST NOTED IS UNKNOWN. AN INVESTIGATION HAS BEEN INITIATED AND ANY ADDITIONAL INFORMATION WILL BE REPORTED IN THE FINAL REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCREPANT RESULTS BETWEEN TWO METERS AND THE LAB FOR THREE PATIENTS: PATIENT: 1, INRATIO1: 2.8, INRATIO2: 3.3, LAB: 3.4. PATIENT: 2, INRATIO1: 4.0, INRATIO2: 3.0. PATIENT: 3, INRATIO1: 2.2, INRATIO2: 1.7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC. BG3502-5-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other C02 LASER