BEUDAMED
    FDA Adverse Event Other Summary report: N

    OCTYLSEAL

    MDR report key: 2141091 · Received June 15, 2011

    Report

    Report Number
    1417592-2011-00031
    Event Type
    Other
    Date Received
    June 15, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 3, 2011
    Manufacturer
    CHEMENCE MEDICAL PRODUCTS, INC.
    Product Code
    MPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD A SPINAL PROCEDURE ON (B)(6) 2011. ON (B)(6) 2011, DURING THE SCHEDULED POST OP VISIT, THE SURGEON IDENTIFIED A PUSTULE-LIKE SKIN REACTION ON AND AROUND THE SURGICAL INCISION. THE SKIN REACTION EXTENDED UP THE PATIENT'S BACK. SHE WAS TREATED WITH BENADRYL AND PREDNISONE. THE PATIENT HAD A PREVIOUS SPINAL SURGERY ON (B)(6) 2011. DERMABOND SURGICAL ADHESIVE WAS USED AT THAT TIME AND THE PATIENT DEVELOPED A SKIN REACTION ON THE INCISION. THERE WERE NO PREVIOUSLY REPORTED KNOWN ALLERGIES FOR THIS PATIENT.

    Description of Event or Problem · 1

    A PATIENT DEVELOPED A SEVERE SKIN REACTION UNDER AND SURROUNDING THE SURGICAL ADHESIVE. THIS PATIENT HAD A PREVIOUS REACTION TO DERMABOND. SHE WAS TREATED WITH PREDNISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTYLSEAL TISSUE ADHESIVE MPN CHEMENCE MEDICAL PRODUCTS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention