BEUDAMED
    FDA Adverse Event Other Summary report: N

    OCTYLSEAL

    MDR report key: 3082396 · Received April 16, 2013

    Report

    Report Number
    3010034760-2013-00001
    Event Type
    Other
    Date Received
    April 16, 2013
    Date of Event
    October 4, 2012
    Report Date
    April 16, 2013
    Manufacturer
    CHEMENCE MEDICAL PRODUCTS INC.
    Product Code
    MPN
    PMA / PMN Number
    K101276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR (CMPI) INITIALLY RECEIVED NOTIFICATION THAT AN MDR HAD BEEN FILED BY THE USER FACILITY ON (B)(6) 2013. THERE WERE 3 REPORTS FILED BY THE RM AS THE RESULT OF AN INVESTIGATION CONDUCTED IN (B)(6) 2013. (B)(6), WAS INTERVIEWED BY PHONE ON (B)(6) 2013. THIS PT WAS AN EMPLOYEE OF THE HOSPITAL AND DID NOT REPORT THE ISSUE UNTIL AN INVESTIGATION WAS BEING CONDUCTED SEVERAL MONTHS LATER FOR THE ISSUE RAISED IN UF# (B)(4). THE DISTRIBUTOR OF THE PRODUCT, (B)(4), WAS CONTACTED BY THE USER FACILITY AND ACCORDING TO REPORT FROM THE RISK MANAGER, THE (B)(4) SALES REP WAS CALLED IN TO SERVICE THE ACCOUNT. (B)(4) DID NOT NOTIFY CMPI THAT AN ADVERSE EVENT HAD BEEN REPORTED AND THE USER FACILITY WAS UNAWARE THAT CMPI WAS THE DEVICE MFR. CMPI CONTACTED (B)(4) ON (B)(6) 2013, BUT NO ADDITIONAL INFORMATION COULD BE GAINED. LOT NUMBER INFORMATION WAS NOT PROVIDED AND A DETAILED INVESTIGATION COULD NOT BE COMPLETED FOR THIS SPECIFIC INCIDENT. THE RISK MANAGER FROM THE USER FACILITY BELIEVED THE PT DID NOT LIKE THE PRODUCT (BECAUSE SHE WORKED AT THE HOSPITAL AND HAD USED IT BEFORE) SO WHEN THEY ASKED FOR FEEDBACK SHE RESPONDED NEGATIVELY. CMPI IS FILING THIS REPORT AS A FOLLOW-UP TO THE REPORT FILED BY THE USER FACILITY ON (B)(6) 2013. SOME PTS ARE SENSITIVE TO CYANOACRYLATE AND SKIN REACTIONS MAY OCCUR ACCORDING TO DEVICE LABELING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE TO DETERMINE HOW THE DEVICE WAS USED OR HOW THE PT WAS TREATED AT THE TIME THE EVENT OCCURRED AND NO LOT NUMBER INFORMATION IS AVAILABLE TO ENABLE A MORE DETAILED INVESTIGATION.

    Description of Event or Problem · 1

    THE PT REPORTED REDNESS AND IRRITATION AT THE SURGICAL SITE WHERE THE ADHESIVE WAS APPLIED FOLLOWING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163147 OCTYLSEAL HIGH VISCOSITY TISSUE ADHESIVE MPN CHEMENCE MEDICAL PRODUCTS INC. OCT70406 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other