BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 9939168 · Received April 8, 2020

    Report

    Report Number
    2210968-2020-02794
    Event Type
    Injury
    Date Received
    April 8, 2020
    Report Date
    March 11, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). H6 PATIENT CODE: 3189 - SURGICAL INTERVENTION. 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. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED (MONOCRYL SUTURE) 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 (MONOCRYL SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS. CITATION: HINDAWI INTERNATIONAL JOURNAL OF OTOLARYNGOLOGY VOLUME 2018, ARTICLE ID 9093545, 5 PAGES.

    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 HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED (MONOCRYL SUTURE) 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 (MONOCRYL SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS CITATION: HINDAWI INTERNATIONAL JOURNAL OF OTOLARYNGOLOGY VOLUME 2018, ARTICLE ID 9093545, 5 PAGES / HTTPS://DOI.ORG/10.1155/2018/9093545. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: AN IMPROVED METHOD FOR TEMPORARY SUTURE MEDIALISATION OF THE MIDDLE TURBINATES FOLLOWING ENDOSCOPIC SINUS SURGERY" AUTHOR: EUGENEWONG AND NARINDER SINGH. CITATION: HINDAWI INTERNATIONAL JOURNAL OF OTOLARYNGOLOGY VOLUME 2018, ARTICLE ID 9093545, 5 PAGES / HTTPS://DOI.ORG/10.1155/2018/9093545. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO DESCRIBE THE METHOD OF SUTURE PLACEMENT THAT PROVIDES A SECURE TEMPORARY MIDDLE TURBINATE MEDIALIZATION WITHOUT THE TECHNICAL CHALLENGES OF TRADITIONAL TECHNIQUES, USING A SUTURE MATERIAL THAT PROVIDES HIGH TENSILE STRENGTH AND APPROPRIATE TIME TO DISSOLUTION. BETWEEN 2012 AND 2013, A TOTAL OF 25 PATIENTS UNDERWENT SINONASAL PROCEDURES WITH THE NEW TECHNIQUE AND ASSESS FOR MIDDLE TURBINATE LATERALISATION WITH ADHESION FORMATION (MITLAF). A 4-0 MONOCRYL (POLIGLECAPRONE 25, ETHICON) SUTURE ON A 19 MM PRECISION POINT REVERSE CUTTING PS-2 CURVED NEEDLE IS HAND-TIED AT THE CAUDAL END OF THE SEPTUM. A SERIES OF PASSES ARE MADE THROUGH THE SEPTUM, EACH AROUND 1CM POSTERIOR TO THE PREVIOUS ONE, UNTIL THE ANTERIOR MARGIN OF THE MT IS REACHED. AN INITIAL PASS IS MADE INCORPORATING THE RIGHT MT AND THE SEPTUM ALONE. THE NEEDLE TIP IS THEN GRASPED ON THE LEFT SIDE BETWEEN THE SEPTUM AND LEFT MT. THE NEEDLE IS REVERSED AND PASSED THROUGH THE LEFT MT AND SEPTUM ALONE. THE NEEDLE TIP IS THEN GRASPED ON THE RIGHT SIDE BETWEEN THE SEPTUM AND RIGHT MT AND PULLED TIGHT. THE SUTURE IS THEN PASSED ANTERIORLY WITH 1CM PASSES. THE SUTURE IS HAND-TIED TO THE ORIGINAL KNOT AND DIVIDED. MIDDLE TURBINATE SUTURING TECHNIQUE INCORPORATING SEPTOPLASTY QUILTING STITCH. POSTOPERATIVE COMPLICATION AT TWO WEEKS INCLUDED MINOR UNILATERAL MITLAF (N=2) WHEREIN, IN ONE CASE, THE ADHESION WAS DIVIDED IN THE OFFICE AT 2 WEEKS, WITH NO FURTHER COMPLICATIONS; AND IN THE OTHER CASE, ASYMPTOMATIC CASE, THE ADHESION WAS DEEMED OF LIMITED SIGNIFICANCE AND NO INTERVENTION WAS UNDERTAKEN. THE PATIENT REMAINED SYMPTOM-FREE AT THE LAST POSTOPERATIVE VISIT AT 8 WEEKS. THE METHOD IS SIMPLE, EASY TO PERFORM, AND HIGHLY EFFECTIVE AND PREVENTS ADHESION FORMATION WITHOUT THE NEED FOR POSTOPERATIVE SPLINTS OR PACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397881 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention