BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7364795 · Received March 23, 2018

    Report

    Report Number
    2210968-2018-71628
    Event Type
    Injury
    Date Received
    March 23, 2018
    Report Date
    March 14, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE ENTITLED: RECURRENCE MECHANISMS AFTER INGUINAL HERNIA REPAIR BY THE ONSTEP TECHNIQUE: A CASE SERIES AUTHOR(S): S. OBERG, K. ANDRESEN, D. HAUGE2, J. ROSENBERG CITATION: HERNIA (2016) 20:681¿685; DOI 10.1007/S10029-016-1496-4. THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE RECURRENCES AFTER ONSTEP OPERATION FOR INGUINAL HERNIAS, AND THUS SUGGEST METHODS TO IMPROVE THE TECHNIQUE. BETWEEN DEC2011 AND APR2015, 565 MALE PATIENTS, AGES 17 TO 19 YEARS, WITH 569 INGUINAL HERNIAS UNDERWENT ONSTEP REPAIR. THERE WERE A TOTAL OF 26 RECURRENCES, 18 OF THESE WAS NOTED ON THE FIRST HALF OF THE OBSERVATIONAL PERIOD, WHILE 8 WERE NOTED IN THE SECOND HALF. THE ONSTEP MESH (POLYSOFT MESH) IS MEDIALLY PLACED THROUGH AN OPENING IN FASCIA TRANSVERSALIS AND LATERALLY, IT IS SUTURED AROUND THE SPERMATIC CORD. AND IN ONE PATIENT, VICRYL SUTURES WERE UTILIZED AROUND THE SPERMATIC CORD. ONE PATIENT HAD VICRYL SUTURES BROKEN AROUND THE SPERMATIC CORD, RESULTING IN A RECURRENCE THROUGH AN OPEN MESH LATERALLY WITHOUT DISPLACEMENT OF THE MESH AND THIS PATIENT WAS RE-OPERATED. THE MAIN REASONS FOR RECURRENCE MAY BE BROKEN SUTURES IN THE MESH LATERALLY OR A SUBOPTIMAL SIZE OF THE OPENING IN FASCIA TRANSVERSALIS MEDIALLY, ENABLING THE MESH TO DISPLACE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208608 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention