BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 19124361 · Received April 17, 2024

    Report

    Report Number
    2210968-2024-04420
    Event Type
    Injury
    Date Received
    April 17, 2024
    Date of Event
    June 18, 2023
    Report Date
    April 17, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-04418, 2210968-2024-04419, 2210968-2024-04420 CITATIONS : HERNIA.1-7. HTTPS://DOI.ORG/10.1007/S10029-023-02829-5

    Description of Event or Problem · 0

    TITLE : HOW I DO IT: USING A HAMMOCK MESH IN THE RECONSTRUCTION OF INGUINAL LIGAMENT DURING A WIDE EN-BLOC RESECTION OF A GROIN MESENCHYMAL TUMOR THE AIM OF THIS STUDY WAS TO ENSURE SAFE REMOVAL WITHOUT TUMOR RUPTURE, STS OF THE GROIN AREA, RETROPERITONEAL OR PELVIC MESENCHYMAL TUMORS MAY REQUIRE INCISION OR RESECTION OF THE INGUINAL LIGAMENT. SOLID RECONSTRUCTION IS MANDATORY TO PREVENT EARLY AND LATE POSTOPERATIVE FEMORAL HERNIAS. WE PRESENT HERE A NEW TECHNIQUE OF INGUINAL LIGAMENT RECONSTRUCTION. SYNTHETIC, MONOFILAMENT, NON-ABSORBABLE (PROLENE 2/0, ETHICON©, USA), STITCHES WERE USED TO ANCHOR THE MESH TO THE PERITONEUM, THE PUBIS, THE ILIO-PUBIC LINE, AND THE ANTERIOR SUPERIOR ILIAC SPINE. IN CASES WHERE WE HAD A TENSION FREE APPROXIMATION OF THE LIGAMENT EDGES, SEVERAL U-SHAPED STITCHES OF ABSORBABLE, SYNTHETIC, BRAIDED SUTURES (VICRYL 0, ETHICON©, USA) WERE USED TO COVER THE MESH. THE ANTERIOR APONEUROTIC FASCIA CLOSURE WAS THEN PERFORMED WITH SYNTHETIC ABSORBABLE MONOFILAMENT SUTURE BY RUNNING SUTURES (PDS II 2/0 ETHICON, USA) AND STITCHED TO THE SUTURED INGUINAL LIGAMENT AND/OR FLAPS. THE REPORTED COMPLICATIONS INCLUDED SURGICAL SITE INFECTION (N=1). IN CONCLUSION, WE HAVE DESCRIBED A NOVEL SURGICAL TOOL FOR INGUINAL ARCADE RECONSTRUCTION USING A PROGRESSIVELY RESORBABLE MESH AS A HAMMOCK AND SHOWING THAT IT IS A SAFE AND EFFECTIVE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023726 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention