BEUDAMED
    FDA Adverse Event Other Summary report: N

    OCTYLSEAL

    MDR report key: 3175075 · Received April 19, 2013

    Report

    Report Number
    3010034760-2013-00007
    Event Type
    Other
    Date Received
    April 19, 2013
    Date of Event
    August 1, 2012
    Report Date
    April 19, 2013
    Manufacturer
    CHEMENCE MEDICAL PRODUCTS, INC.
    Product Code
    MPN
    PMA / PMN Number
    K101276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR OF OCTYLSEAL, (B)(4), RECEIVED THE INITIAL COMPLAINT FROM THE USER FACILITY AND DID NOT NOTIFY THE MANUFACTURER, CHEMENCE MEDICAL PRODUCTS, INC. (CMPI) THAT A COMPLAINT WAS RECEIVED ((B)(6) 2012) OR THAT AN MDR WOULD BE FILED. (B)(4) FILED THE INITIAL MDR ON BEHALF OF CMPI ON (B)(6) 2012. DURING PERIODIC REVIEW OF PREVIOUSLY FILED MDRS, CMPI NOTED THAT WE, AS THE MANUFACTURER, NEVER FILED AN MDR FOR THIS EVENT. THE PURPOSE OF THIS REPORT IS TO DOCUMENT THE EVENT ON BEHALF OF THE MANUFACTURER OF OCTYLSEAL, CMPI. LOT NUMBER INFORMATION WAS NOT PROVIDED AND A DETAILED INVESTIGATION COULD NOT BE COMPLETED FOR THIS SPECIFIC INCIDENT. THE ROOT CAUSE OF THE INFECTION WAS NEVER IDENTIFIED, BUT THERE IS NO EVIDENCE TO SUGGEST IT WAS CAUSED BY THE TISSUE ADHESIVE. THE MANUFACTURERS NARRATIVE FROM THE (B)(4) MDR READS, "A SURGEON REPORTED AN INCREASE IN POST OP INFECTIONS FROM SOME OF HIS PATIENTS FOLLOWING APPENDECTOMIES. HE RAISED A CONCERN THAT THE TISSUE ADHESIVE WAS THE SOURCE OF THE INFECTION. WE WERE PROVIDED WITH NO EVIDENCE OR SUPPORTING DOCUMENTATION TO INDICATE THAT THE PRODUCT CAUSED THE POST OP INFECTIONS. WE RECEIVED NO OTHER SIMILAR REPORTS FROM THE OTHER SURGEONS AT THE FACILITY. NO SAMPLES WERE PROVIDED FOR EVAL AND NO LOT NUMBER WAS GIVEN. NO ADD'L INFO WAS PROVIDED FOR EVAL AND NO LOT NUMBER WAS GIVEN. NO ADD'L INFOR WAS PROVIDED FROM THE SURGEON OR THE FACILITY. WE HAVE NO INFO TO SUGGEST THE TISSUE ADHESIVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENTS BUT IN THE ABUNDANCE OF CAUTION THIS MEDWATCH IS BEING FILED."

    Description of Event or Problem · 1

    A SURGEON REPORTED TO THE DISTRIBUTOR (B)(4) THAT HE HAD SEEN AN INCREASE IN POST OP INFECTIONS AND IN THE ABSENCE OF ANY CONFIRMED ROOT CAUSE, HE RAISED THE CONCERN THAT THE OCTYLSEAL WAS THE CONTRIBUTING FACTOR. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171413 OCTYLSEAL HIGH VISCOSITY TISSUE ADHESIVE MPN CHEMENCE MEDICAL PRODUCTS, INC. OCT70406 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other