BEUDAMED
    FDA Adverse Event Other Summary report: N

    OCTYLSEAL

    MDR report key: 3175077 · Received April 19, 2013

    Report

    Report Number
    3010034760-2013-00005
    Event Type
    Other
    Date Received
    April 19, 2013
    Date of Event
    May 31, 2011
    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, MEDLINE, 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) 2011) OR THAT AN MDR WOULD BE FILED. MEDLINE FILED THE INITIAL MDR ON BEHALF OF CMPI ON (B)(6) 2011. 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. LONG INCISIONS IN HIGH STRESS AREAS OF THE BODY MAY REQUIRE THE APPLICATION OF SUTURES OR STERI-STRIPS TO AID IN WOUND APPROXIMATION WHEN CLOSING INCISIONS USING TOPICAL TISSUE ADHESIVES. THE DEVICE WAS NOT RETURNED NOR IS THERE ANY ADDITIONAL INFORMATION AVAILABLE TO ENABLE A MORE DETAILED INVESTIGATION. ALTHOUGH THE DISTRIBUTOR REPORTED THAT THE ROOT CAUSE COULD NOT BE DETERMINED IN THIS CASE, IMPROPER APPLICATION TECHNIQUE (NOT ENOUGH ADHESIVE) OR POOR POST-OP CARE OF THE WOUND COULD POSSIBLY LEAD TO PREMATURE WOUND DEHISCENCE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR IN WHICH OCTYLSEAL WAS USED TO CLOSE THE INCISION. THE INCISION WAS FOUR INCHES LONG. THE ENDS OF THE INCISION OPENED SLIGHTLY ON THE SECOND POST OP DAY AND REQUIRED THE APPLICATION OF STERI-STREIPS TO APPROXIMATE THE WOUND. NO OTHER POST-OP COMPLICATION WAS NOTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171411 OCTYLSEAL HIGH VISCOSITY ISSUE ADHESIVE MPN CHEMENCE MEDICAL PRODUCTS, INC. OCT70406 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention