BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGISEAL TOPICAL SKIN ADHESIVE

    MDR report key: 6178716 · Received December 15, 2016

    Report

    Report Number
    3006385287-2015-00006
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    January 1, 2015
    Report Date
    October 12, 2016
    Manufacturer
    ADHEZION BIOMEDICAL, LLC
    Product Code
    MPN
    UDI-DI
    M495SS035T1
    PMA / PMN Number
    K082993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT ORIGINALLY RECEIVED ON 10/26/2015. UPON REVIEW, IT WAS INCORRECTLY DETERMINED THAT THE ADVERSE EVENT WAS NOT REPORTABLE. UPON FURTHER REVIEW, AND TO ERR ON THE SIDE OF SAFETY, IT WAS DECIDED THAT AN MDR SHOULD BE FILED. A PHYSICIAN'S OFFICE WAS THE INITIAL REPORTER, AND MANY ATTEMPTS WERE MADE TO INVESTIGATE THE ALLEGED EVENT. UPON CONTACT WITH THE REPORTER, SCANT INFORMATION WAS SHARED WITH THE MANUFACTURER, AND THE PATIENT WAS NOT AVAILABLE TO ELABORATE OR CONFIRM ANY DETAILS. SHOULD ANY ADDITIONAL DETAILS BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NURSE REPORTED THAT THE PATIENT EXPERIENCED REDNESS AND OOZING AT THE INCISION SITE FIVE DAY AFTER SURGERY. NO OTHER APPLICATIONS WERE KNOWN, BY THE COMPLAINANT, TO BE APPLIED TO THE PATIENT, AND THE PATIENT HAD NO KNOWN ALLERGIES. THE COMPLAINANT DOES NOT KNOW THE LOT NUMBER OF THE MATERIAL, NOR THE SUPPLIER (DISTRIBUTOR) THAT PROVIDED SURGISEAL. THE PATIENT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827770 SURGISEAL TOPICAL SKIN ADHESIVE SURGISEAL "TEARDROP" MPN ADHEZION BIOMEDICAL, LLC SS035-T M495SS035T1

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other