BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERCEED (TC7) UNKNOWN PRODUCT

    MDR report key: 10705987 · Received October 20, 2020

    Report

    Report Number
    2210968-2020-08147
    Event Type
    Injury
    Date Received
    October 20, 2020
    Report Date
    September 24, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    MCN
    PMA / PMN Number
    P880047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO CLARIFY THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER FOR EACH PATIENT? DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT (TVT) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (TVT) INVOLVED? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: DOI: REPROD MED BIOL. 2019;18:378¿383

    Description of Event or Problem · 1

    TITLE: EFFICACY OF SILICONE SHEET AS A PERSONALIZED BARRIER FOR PREVENTING ADHESION REFORMATION AFTER HYSTEROSCOPIC ADHESIOLYSIS OF INTRAUTERINE ADHESIONS THE AIM OF THIS NON-RANDOMIZED RETROSPECTIVE STUDY IS TO EVALUATE THE EFFICACY OF SILICONE SHEET AS A NEW TYPE OF BARRIER FOR PREVENTING ADHESION REFORMATION FOLLOWING HYSTEROSCOPIC ADHESIOLYSIS OF INTRAUTERINE ADHESIONS (IUAS). BETWEEN NOV 2004 AND AUG 2014, 36 FEMALE PATIENTS UNDERWENT HYSTEROTROPIC ADHESIOLYSIS FOR INTRAUTERINE ADHESIONS (IUAS). THE PATIENTS WERE DIVIDED INTO TWO GROUPS: GROUP 1 (N=26 PATIENTS WITH AGE OF 35.3 ± 4.0 TREATED WITH SILICONE SHEET) AND GROUP 2 (N=10 PATIENTS WITH AGE OF 37.4 ± 2.8 TREATED WITH AN INTRAUTERINE DEVICE (IUD) WRAPPED IN OXIDIZED REGENERATED CELLULOSE (ORC) AS A BARRIER). FOR THE PATIENTS IN GROUP 2, THE IUD WAS MANUALLY WRAPPED WITH INTERCEED ORC (JOHNSON AND JOHNSON) (1/4 OF THE ORIGINAL 12.7 × 15.2 CM2 SIZE) AND INSERTED INTO THE UTERINE CAVITY USING SMALL PLACENTAL FORCEPS. FOR SMOOTH INSERTION OF THE IUD WRAPPED IN ORC, THE CERVICAL CANAL WAS DILATED SUFFICIENTLY. ADHESION REFORMATION OCCURRED IN FOUR (4) PATIENTS AND MISCARRIAGE OCCURRED IN ONE (1) PATIENT TREATED WITH IUD WRAPPED IN ORC. USE OF SILICONE SHEETS APPEARS TO BE EFFECTIVE FOR PREVENTING ADHESION REFORMATION FOLLOWING HYSTEROSCOPIC ADHESIOLYSIS OF IUAS. THIS IS THE FIRST STUDY TO INVESTIGATE THE EFFICACY OF SILICONE SHEET USED AS A PERSONALIZED BARRIER FOR PREVENTING IUAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169728 INTERCEED (TC7) UNKNOWN PRODUCT BARRIER, ABSORBABLE, ADHESION MCN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1