BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERCEED (TC7) ABSORBABLE ADHESION BA

    MDR report key: 1900015 · Received November 9, 2010

    Report

    Report Number
    2210968-2010-01482
    Event Type
    Injury
    Date Received
    November 9, 2010
    Report Date
    October 9, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    MCN
    PMA / PMN Number
    P880047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (INFECTION). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A LAPAROSCOPIC MYOMECTOMY (MULTIPLE SUBSEROSAL MYOMA LARGEST 7 X 7CM) PROCEDURE ON AN UNK DATE AND ABSORBABLE ADHESION BARRIER WAS USED. TEN DAYS AFTER DISCHARGE, THE PT VISITED AN EMERGENCY ROOM WITH A COMPLAINT OF ABDOMINAL PAIN AND FEVER AND LEUKOCYTOSIS (WBC 18600/UL) AND CRP ELEVATION (116.2 MG/L). AFTER INEFFECTIVE ANTIBIOTICS TREATMENT, A DIAGNOSTIC LAPAROSCOPY WAS THEN ARRANGED (45 DAYS AFTER INITIAL LAPAROSCOPIC MYOMECTOMY) AND FOUND SEVERE PELVIC ABSCESS FORMATION AND DENSE ADHESION WITH PSEUDOCYST OF THE CUL-DE-SAC. PRIOR UTERINE WOUND COVER WITH OXIDIZED REGENERATED CELLULOSE BARRIER WAS NOW DENSE ADHESION AND NECROTIC DEBRIS. ADHESIOLYSIS AND PELVIC IRRIGATION WITH NECROTIC DEBRIS REMOVAL WERE PERFORMED AND A RETENTION DRAINAGE TUBE PLACED TRANSABDOMINALLY. POST-OPERATIVELY ANTIBIOTICS CONTINUED AND THE PT RECOVERED WELL AND WAS DISCHARGED UNEVENTFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERCEED (TC7) ABSORBABLE ADHESION BA BARRIER, ABSORB, ADHESION MCN ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention