BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADEPT ADHESION REDUCTION SOLUTION

    MDR report key: 2063554 · Received April 19, 2011

    Report

    Report Number
    2954761-2011-00016
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    October 11, 2010
    Report Date
    April 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - VIENNA
    Product Code
    MCN
    PMA / PMN Number
    P050011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THIS IS A REPORT OF A PATIENT WHO UNDERWENT LAPAROSCOPIC OVARIAN CYSTECTOMY WITH LYSIS OF ADHESIONS. ADEPT WAS ADMINISTERED PRIOR TO EXSUFFLATION, AFTER WHICH THE TROCAR WOUNDS WERE SUTURED CLOSED (10MM INCLUDING THE APONEUROSIS, BUT 5MM SUBCUTANEOUSLY AND SKIN ONLY). EIGHT HOURS POSTOPERATIVELY THE PATIENT COMPLAINED OF PAIN IN HER RIGHT FLANK WHERE BULGING (VOUSSURE) ALL ALONG THE RIGHT FLANK WAS NOTED. THE PAIN RELATED TO THIS BULGE CONTINUED TO INCREASE LEADING TO THE PATIENT BEING REOPERATED ON AND THE FINDINGS OF BOTH GAS (TISSUE EMPHYSEMA) AND ADEPT INFILTRATION INTO THE SUBCUTANEOUS TISSUES WAS CONFIRMED AND TREATED. THE LACK OF SUTURE CLOSURE OF THE APONEUROSIS IN BOTH 5MM TROCAR PORTS LEFT THIS AREA WEAKENED. THE INCREASE IN PRESSURE AGAINST THIS WEAKENED AREA CAUSED BY INSUFFICIENT EXSUFFLATION OF THE GAS PRIOR TO LAPAROSCOPE REMOVAL AND BY THE INSTALLATION OF 1 LITER OF FLUID LEAD TO INFILTRATION OF BOTH GAS AND LIQUID. USER ERROR IN INADEQUATE CLOSURE OF THE TROCAR PORT HOLES AND INSUFFICIENT REMOVAL OF THE GAS USED DURING LAPAROSCOPY LEAD TO A SITUATION WHERE INFILTRATION WITH ANY LIQUID WOULD FURTHER INCREASE THE PRESSURE INABDOMINALLY. THIS IS NOT A RESULT OF THE USE OF ADEPT ALONE, BUT THE USE OF ADEPT UNDER THESE CIRCUMSTANCES LEAD TO THE INFILTRATION OF IT INTO THE SUBCUTANEOUS TISSUES. (B)(4). NO FURTHER INVESTIGATION IS REQUIRED. THIS IS THE FIRST COMPLAINT OF THIS NATURE RECEIVED FOR THIS PRODUCT LOT. THIS COMPLAINT WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A (B)(6) FEMALE PATIENT (B)(6) EXPERIENCED CLINICAL SYMPTOMS AFTER A SURGERY, IN WHICH ADEPT WAS USED. ACCORDING TO THE REPORTER, THIS PATIENT WAS UNDERGOING A COELIOSCOPY FOR THE EXERESIS OF A LEFT OVARIAN ENDOMETRIOTIC CYST. THE SURGERY ALSO INCLUDED AN ADHESIOLYSIS PROCEDURE. AT THE END OF THE SURGERY, APPROXIMATELY 1 LITER OF ADEPT WAS ADMINISTERED; BUT PNEUMOPERITONEUM WAS EXSUFFLATED AFTER THE PRODUCT WAS PUT IN PLACE. SEALING OF TROCARS ORIFICES WAS PERFORMED ACCORDING TO THE USUAL PRACTICES: THE APONEUROSIS WAS SEALED ON THE 10 MM SUBUMBILICAL AND SUPRAPUBIC INCISION; BOTH TROCARS ORIFICES, AT THE LEVEL OF THE LEFT AND RIGHT ILIAC FOSSA (MEASURING 5MM), WERE SEALED AT A SUBCUTANEOUS AND CUTANEOUS LEVEL. THE FIRST POST SURGICAL EVOLUTION WAS SIMPLE; PAIN APPEARED AT THE LEVEL OF THE RIGHT FLANK 8 HOURS AFTER THE THERAPY. A VOUSSURE WAS NOTICED ALONG THE RIGHT FLANK, COUPLED WITH INTENSE PAIN. THE PATIENT EXAMINATION LED TO SUSPICION OF A HAEMOPERITONEUM, LEADING TO A SECOND SURGERY. DURING THIS SECOND INTERVENTION, THE DIAGNOSIS OF A SUBCUTANEOUS TRANSUDATE WAS CONFIRMED. REPORTEDLY, ADEPT COUPLED WITH GAS WAS OBSERVED IN THE SUBCUTANEOUS AREA OF THE RIGHT FLANK. THE OEDEMA WSA REMOVED BY SIMPLE MANUAL PRESSURE ON THE PATIENT'S SKIN. THE EVOLUTION OF THE PATIENT WAS SIMPLE AFTER THAT, AND DID NOT REQUIRE ANY COMPLEMENTARY TREATMENT. THE PATIENT LEFT THE HOSPITAL AT J5 (5 DAYS AFTER THE FIRST INTERVENTION) WITHOUT ANY SEQUELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADEPT ADHESION REDUCTION SOLUTION BARRIER, ABSORABLE, ADHESION MCN BAXTER HEALTHCARE - VIENNA 09973002C

    Patients

    Seq Age Sex Outcome Treatment
    1 22