BEUDAMED
    FDA Adverse Event Other Summary report: N

    OCTYLSEAL

    MDR report key: 3175076 · Received April 19, 2013

    Report

    Report Number
    3010034760-2013-00004
    Event Type
    Other
    Date Received
    April 19, 2013
    Date of Event
    May 11, 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, (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)(4) 2011) OR THAT AN MDR WOULD BE FILED. (B)(4) FILED THE INITIAL MDR ON BEHALF OF CMPI ON (B)(4) 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. SOME PATIENTS ARE SENSITIVE TO CYANOACRYLATE AND SKIN REACTIONS MAY OCCUR ACCORDING TO DEVICE LABELING. IT WAS NOTED IN THE INITIAL REPORT THAT THIS PATIENT HAD A KNOWN SENSITIVITY TO CA ADHESIVE AS SHE HAD BEEN PREVIOUSLY TREATED WITH DERMABOND AND HAD A SIMILAR REACTION. DERMABOND AND OCTYLSEAL ARE SUBSTANTIALLY EQUIVALENT. THE DEVICE WAS NOT RETURNED NOR IS THERE ANY ADDITIONAL INFORMATION AVAILABLE TO ENABLE A MORE DETAILED INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED A SEVERE SKIN REACTION UNDER AND SURROUNDING THE SURGICAL ADHESIVE. THIS PATIENT HAD A SIMILAR REACTION TO DERMABOND DURING A PREVIOUS SURGERY. THE REACTION WAS "PUSTULE-LIKE" ON AND AROUND THE SURGICAL INCISION AND WAS NOTICED AT A POST OP VISIT. SHE WAS TREATED WITH PREDNISONE AND BENADRYL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171412 OCTYLSEAL HIGH VISCOSITY TISSUE ADHESIVE MPN CHEMENCE MEDICAL PRODUCTS, INC. OCT70406 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention