BEUDAMED
    FDA Adverse Event Other Summary report: N

    OCTYSEAL

    MDR report key: 3082381 · Received April 16, 2013

    Report

    Report Number
    3010034760-2013-00002
    Event Type
    Other
    Date Received
    April 16, 2013
    Date of Event
    February 2, 2013
    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 (B)(6) INITIALLY RECEIVED NOTIFICATION THAT AN MDR HAD BEEN FILED BY THE USER FACILITY ON (B)(6) 2013. THERE WERE 3 REPORTS FILED BY THE RN AS THE RESULT OF AN INVESTIGATION CONDUCTED IN (B)(6) 2013. THE RM, K. WAUGH, WAS INTERVIEWED BY PHONE ON (B)(6) 2013. THIS PT EXPERIENCED AN ADVERSE (ALLERGIC) REACTION BUT IT WAS NOT REPORTED TO THE RM UNTIL AN INVESTIGATION WAS BEING CONDUCTED SEVERAL MONTHS LATER FOR THE ISSUE RAISED IN UF# (B)(4). THE DISTRIBUTOR OF THE PRODUCT, MEDLINE, WAS CONTACTED BY THE USER FACILITY AND ACCORDING TO REPORT FROM THE RM, THE MEDLINE SALES REP WAS CALLED IN TO SERVICE THE ACCOUNT. MEDLINE DID NOT NOTIFY (B)(4)THAT AN ADVERSE EVENT HAD BEEN REPORTED AND THE USER FACILITY WAS UNAWARE THAT (B)(4) WAS THE DEVICE MFR. (B)(4) CONTACTED MEDLINE ON (B)(4) 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 RM RECALLED THAT THE PT WAS TREATED WITH ANTIHISTAMINE SUCCESSFULLY. (B)(4) IS FILING THIS REPORT AS A FOLLOW-UP TO THE REPORT FILED BY THE USER FACILITY ON (B)(4) 2013. SOME PTS ARE SENSITIVE TO CYANOACRYLATE AND SKIN REACTIONS AND EVEN ALLERGIC REACTIONS LIKE THIS ONE 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 RETURNED TO THE EMERGENCY DEPARTMENT POST-OP FROM NECK SURGERY AND BELIEVED TO BE HAVING A REACTION TO THE ADHESIVE. PT HAD SHORTNESS OF BREATH, SOME LIP SWELLING AND PAIN AT THE SURGICAL SITE ON HIS NECK. THE ADHESIVE WAS USED TO CLOSE AN INCISION FOLLOWING A CERVICAL PROCEDURE. TREATED WITH ANTIHISTAMINE. (FROM USER FACILITY REPORT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163146 OCTYSEAL HIGH VISCOSITY TISSUE ADHESIVE MPN CHEMENCE MEDICAL PRODUCTS INC. OCT70406 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention