BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTYLSEAL SURGICAL ADHESIVE

    MDR report key: 3059547 · Received April 9, 2013

    Report

    Report Number
    1417592-2013-00027
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    February 26, 2013
    Report Date
    April 4, 2013
    Manufacturer
    CHEMENCE MEDICAL PRODUCTS, INC.
    Product Code
    MPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SURGICAL ADHESIVE HAD BEEN USED TO CLOSE A LAPAROSCOPIC INCISION. IT WAS REPORTED THAT A DEHISCENCE OF THE INCISION OCCURRED POST-OPERATIVELY. THE FACILITY DECLINED TO REPORT THE AGE AND/OR SEX OF THE PT BUT INDICATED THE PT WAS A 'BABY'. NO MEDICAL/SURGICAL INTERVENTION WAS INITIATED AS A RESULT OF THE INCIDENT. THE FACILITY REPORTED THAT NO SERIOUS INJURY RESULTED. IT IS NOT KNOWN HOW MANY DAYS POST-OP IT WAS WHEN THE INCIDENT OCCURRED. THERE IS NO SAMPLE TO EVALUATE; NO LOT NUMBER WAS REPORTED. IT IS NOT KNOWN IF THE ADHESIVE WAS ALLOWED TO SUFFICIENTLY DRY AFTER APPLICATION.

    Description of Event or Problem · 1

    A SURGICAL WOUND DEHISCENCE WAS REPORTED FOLLOWING A LAPAROSCOPIC PROCEDURE. NO INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144472 OCTYLSEAL SURGICAL ADHESIVE MPN CHEMENCE MEDICAL PRODUCTS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other