BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 7935867 · Received October 4, 2018

    Report

    Report Number
    2210968-2018-76328
    Event Type
    Injury
    Date Received
    October 4, 2018
    Report Date
    September 10, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    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 OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS 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 PRODUCTS USED IN THIS PROCEDURE? CITATION: PLAST RECONSTR SURG GLOB OPEN. 2016; 4: E1014; DOI: 10.1097/GOX.0000000000001014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE:ABDOMINAL CLOSURE AFTER TRAM FLAP BREAST RECONSTRUCTION WITH TRANSVERSUS ABDOMINIS MUSCLE RELEASE AND MESH" AUTHORS: ANTONIO ESPINOSA-DE-LOS-MONTEROS,MD, HÉCTOR AVENDANO-PEZA, MD, YURI W. NOVITSKY, MD. CITATION: PLAST RECONSTR SURG GLOB OPEN. 2016; 4: E1014; DOI: 10.1097/GOX.0000000000001014. THE AUTHORS PRESENTED A NOVEL TECHNIQUE OF POSTERIOR COMPONENTS SEPARATION WITH TRANSVERSUS ABDOMINIS MUSCLE RELEASE AND RETROMUSCULAR MESH REINFORCEMENT FOR DONOR-AREA CLOSURE DURING PEDICLED TRANSVERSE RECTUS ABDOMINIS MUSCLE (TRAM) FLAP BREAST RECONSTRUCTION. A TOTAL OF 6 PATIENTS UNDERWENT BREAST RECONSTRUCTIONS WITH PEDICLED TRAM FLAPS AND ABDOMINAL DONOR-AREA RECONSTRUCTION WITH PCS/TAR TECHNIQUE. THE AVERAGE AGE WAS 42 YEARS OLD (AGE RANGE: 32¿49 YEARS) AND THE MEAN BODY MASS INDEX WAS 24 KG/M2 (RANGE: 22¿28). DURING THE SURGICAL PROCEDURE, AFTER THE RETROMUSCULAR SPACE HAS BEEN ESTABLISHED, A 30 × 15 CM PROLENE POLYPROPYLENE MESH (ETHICON) IS PLACED OVER BOTH POSTERIOR RECTUS SHEATHS AND THE TRANSVERSALIS FASCIA. AN APERTURE IS MADE IN THE MESH FOR THE UMBILICUS. THIS MESH IS THEN FIXATED TO THE XYPHOID PROCESS SUPERIORLY, TO COOPER¿S LIGAMENT INFERIORLY, TO THE LATERAL MUSCLES ON THE FLAP-HARVEST SIDE, AND TO THE RECTUS MUSCLE ON THE CONTRALATERAL SIDE; THEREFORE, REINFORCEMENT OF THE ENTIRE ABDOMINAL WALL IS ACHIEVED. REPORTED COMPLICATION INCLUDED SKIN-EDGE NECROSIS (N-1) WHICH REQUIRED OUTPATIENT WOUND CARE AND THE WOUND HEALED AFTER 8 WEEKS. THE DEVELOPMENT OF THIS TECHNIQUE DURING CLOSURE OF A PEDICLED TRAM FLAP DONOR AREA RESULTS IN MYOFASCIAL CONTINUITY OF THE ABDOMINAL WALL MUSCULATURE, AND REINFORCEMENT WITH A PROPERLY OVERLAPPED SYNTHETIC MESH PLACED BEHIND THE MUSCLES, WITHOUT PERFORMING EXTRA SUBCUTANEOUS UNDERMINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774806 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention