BEUDAMED
    FDA Adverse Event Other Summary report: N

    OCTYLSEAL

    MDR report key: 3175074 · Received April 19, 2013

    Report

    Report Number
    3010034760-2013-00008
    Event Type
    Other
    Date Received
    April 19, 2013
    Date of Event
    November 28, 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. MEDLINE 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 INFECTIONS WAS NEVER IDENTIFIED, BUT THERE IS NO EVIDENCE TO SUGGEST IT WAS CAUSED BY THE TISSUE ADHESIVE. THE MANUFACTURERS NARRATIVE FROM THE MEDLINE MDR READS, "AN ER PHYSICIAN REPORTED AN INFECTION FOLLOWING THE REPAIR OF TWO SEPARATE FACIAL LACERATIONS AND RAISED THE CONCERN THAT THE TISSUE ADHESIVE WAS THE COURSE OF THE INFECTION. ONE PATIENT HAD A LACERATION ON THE HAIRLINE OF THE FOREHEAD AND THE OTHER PATIENT HAD A LACERATION ON THE EYEBROW. BOTH LACERATIONS WERE APPROX. 1 CM IN LENGTH AND DESCRIBED AS SIMPLE. BOTH DEVELOPED PUS UNDER THE ADHESIVE AND WERE PRESCRIBED ANTIBIOTICS. CULTURE CAME BACK S. AUREUS. NO INFORMATION WAS AVAILABLE FOR THE SECOND PATIENT. NO SAMPLES OR LOT NUMBERS WERE PROVIDED. THERE HAVE BEEN NO OTHER SIMILAR REPORTS FROM OTHER PHYSICIANS AT THE FACILITY. WE HAVE NO EVIDENCE TO SUGGEST THE TISSUE ADHESIVE CAUSED OR CONTRIBUTED TO THE INFECTION BUT IN THE ABUNDANCE OF CAUTION THIS MEDWATCH IS BEING FILED."

    Description of Event or Problem · 1

    AN EMERGENCY ROOM PHYSICIAN REPORTED INFECTIONS FOLLOWING TWO SEPARATE FACILA LACERATION REPAIRS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171410 OCTYLSEAL HIGH VISCOSITY TISSUE ADHESIVE MPN CHEMENCE MEDICAL PRODUCTS, INC. OCT70406 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other