BEUDAMED
    FDA Adverse Event Other Summary report: N

    OCTYSEAL

    MDR report key: 3082397 · Received April 16, 2013

    Report

    Report Number
    3010034760-2013-00003
    Event Type
    Other
    Date Received
    April 16, 2013
    Date of Event
    March 7, 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 (CMPI) INITIALLY RECEIVED NOTIFICATION THAT AN MDR HAD BEEN FILED BY THE USER FACILITY ON (B)(4) 2013. THERE WERE 3 REPORTS FILED BY THE RM AS THE RESULT OF AN INVESTIGATION CONDUCTED IN (B)(4) 2013. THE RM, (B)(6), WAS INTERVIEWED BY PHONE ON (B)(6) 2013. THIS PT UNDERWENT A LUMBAR PROCEDURE AND INCISION WAS TREATED WITH OCTYSEAL. THE GLUE DID NOT DRY BEFORE PT WAS TRANSFERRED TO LINEN AND THE LINEN STUCK TO THE INCISION SITE. THE DISTRIBUTOR OF THE PRODUCT, (B)(4), WAS CONTACTED BY THE USER FACILITY AND ACCORDING TO THE REPORT FROM THE RM, THE (B)(4) SALES REP WAS CALLED IN TO TEACH PROPER APPLICATION TECHNIQUES. (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)(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. ACCORDING TO RM, LINEN SLOUGHED OFF INCISION NATURALLY WITH ADHESIVE WITH NO LONG TERM EFFECTS. NO ADDITIONAL TREATMENT OR INTERVENTION WAS REQUIRED. CPMI IS FILING THIS REPORT AS A FOLLOW-UP TO THE REPORT FILED BY THE USER FACILITY ON (B)(4) 2013. THE GLUE MUST BE APPLIED PROPERLY AND ALLOWED TO DRY COMPLETELY ACCORDING TO DEVICE LABELING. IF APPLIED INCORRECTLY (PUDDLE, POOL), LONGER THAN EXPECTED DRY TIMES MAY BE EXPERIENCED. TRAINING ON PROPER APPLICATION TECHNIQUE IS RECOMMENDED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE TO DETERMINE HOW THE DEVICE WAS USED.

    Description of Event or Problem · 1

    THE PT ARRIVED IN (B)(6) WITH PART OF THE LINEN SHEET GLUED TO HIS INCISION. IT IS BELIEVED THE ADHESIVE HAD NOT DRIED COMPLETELY BEFORE THE PT WAS TURNED ONTO THE LINEN. THE PROCEDURE WAS A LUMBAR FUSION. (FROM USER FACILITY REPORT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164095 OCTYSEAL HIGH VISCOSITY TISSUE ADHESIVE MPN CHEMENCE MEDICAL PRODUCTS INC. OCT70406 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other