BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERCEED* (TC7) ABSORBABLE ADHESION BARRIER

    MDR report key: 2991037 · Received March 6, 2013

    Report

    Report Number
    2210968-2013-02075
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    MCN
    PMA / PMN Number
    P880047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-02074. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC REMOVAL OF AN OVARIAN REMNANT AND LYSIS OF ADHESIONS IN (B)(6) 2011 AND AN ABSORBABLE ADHESION BARRIER WAS USED. MARCAINE WAS A LOCAL ANESTHETIC USED AT THE SURGICAL SITE DURING THE PROCEDURE. A FEW DAYS AFTER THE PROCEDURE, THE PATIENT HAD A FULL BODY DESQUAMINATIVE SKIN RASH. THE PATIENT WAS HOSPITALIZED IN THE ICU AND GIVEN INTRAVENOUS ANTIBIOTICS. THE RASH LASTED APPROXIMATELY ONE TO TWO WEEKS. THE PATIENT'S CONDITION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95695 INTERCEED* (TC7) ABSORBABLE ADHESION BARRIER BARRIER, ABSORB, ADHESION MCN ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R