BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSEAL SURGICAL SEALANT

    MDR report key: 2438848 · Received February 3, 2012

    Report

    Report Number
    2954761-2012-00004
    Event Type
    Injury
    Date Received
    February 3, 2012
    Date of Event
    January 14, 2012
    Report Date
    January 20, 2012
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    NBE
    PMA / PMN Number
    P030039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE REPORTER IN AN EFFORT TO RECEIVE ADDITIONAL CASE INFORMATION (LOT NUMBER). THE DOCTOR PROVIDED NO FURTHER INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER TIME, THE INFORMATION WILL BE EVALUATED AND A FOLLOW-UP SUBMISSION WILL BE SENT. THIS COMPLAINT WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT SUMMARY: PATIENT DEVELOPED ABDOMINAL WOUND INFECTION (ABDOMINAL VAULT SUTURE LINE) IN THE AREA COSEAL HAS BEEN APPLIED FOR ADHESION PREVENTION. FEVER AND ABDOMINAL PAIN AS WELL AS SIGNS OF APPENDICITIS HAVE BEEN NOTED DURING RE-EXPLORATION. WHILE COSEAL IS PROVIDED STERILE, THE VICINITY OF THE INFECTION TO THE ANATOMY WHERE COSEAL HAS BEEN APPLIED DOES NOT ALLOW EXCLUSION OF A CAUSAL RELATIONSHIP. ALTERNATIVE CAUSES ARE SURGERY AND PATHOLOGY RELATED. --------------------------------------------------- ADDITIONAL INFORMATION HAS IS BEING REQUESTED FROM THE REPORTER. UPON RECEIPT AND EVALUATION OF THE ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE GYNAECOLOGIST REPORTED THAT ON (B)(6) 2012, HE PERFORMED AN HYSTERECTOMY ON A PATIENT WHERE HE USED COSEAL ALONG THE VAULT SUTURE LINE. TWO DAYS POST OPERATION THE PATIENT DEVELOPED A TEMPERATURE AND ABDOMINAL PAIN. PATIENT RETURNED TO THEATRE ON (B)(6). UPON OPENING THE PATIENT, THE GYNAECOLOGIST NOTICED THE APPENDIX WAS INFLAMED AND THE VAULT SUTURE LINE WAS INFECTED. COSEAL WAS SEEN BESIDE THE APPENDIX. THE GYNAECOLOGIST STATED THE PATIENT RECOVERED BY (B)(6). HOSPITALIZATION WAS PROLONGED DUE TO INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSEAL SURGICAL SEALANT SEALANT,POLYMERIZING NBE BAXTER HEALTHCARE - HAYWARD

    Patients

    Seq Age Sex Outcome Treatment
    1