BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH UNKNOWN PRODUCT

    MDR report key: 11257243 · Received February 1, 2021

    Report

    Report Number
    2210968-2021-00847
    Event Type
    Injury
    Date Received
    February 1, 2021
    Date of Event
    February 20, 2020
    Report Date
    January 7, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADVERSE EVENTS SUBMITTED VIA 2210968-2021-00843, 2210968-2021-00844, 2210968-2021-00845, 2210968-2021-00846, 2210968-2021-00848, 2210968-2021-00849, AND 2210968-2021-00850. 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.  THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS.  CITATION: HERNIA. 2020; 24: 459¿468. DOI: HTTPS://DOI.ORG/10.1007/S10029-020-02124-7.   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.   WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCTS (VICRYL MESH, VYPRO MESH, ULTRAPRO MESH, PHYSIO MESH, PROCEED MESH, PROLENE MESH, MERSILENE SUTURE, PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WERE ANY DEFICIENCIES WITH THE ETHICON PRODUCTS INVOLVED? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: LONG-TERM OUTCOMES AFTER CONTAMINATED COMPLEX ABDOMINAL WALL RECONSTRUCTION. COMPLEX ABDOMINAL WALL REPAIR (CAWR) IN A CONTAMINATED OPERATIVE FIELD IS A CHALLENGE. AVAILABLE LITERATURE REGARDING LONG-TERM OUTCOMES OF CAWR COMPRISES STUDIES THAT OFTEN HAVE SMALL NUMBERS AND HETEROGENEOUS PATIENT POPULATIONS. THIS STUDY AIMS TO ASSESS LONG-TERM OUTCOMES OF MODIFIED-VENTRAL HERNIA WORKING GROUP (VHWG) GRADE 3 REPAIRS. BECAUSE THE RELEVANCE OF HERNIA RECURRENCE (HR) AS THE PRIMARY OUTCOME FOR THIS PATIENT GROUP IS CONTENTIOUS, THE NEED FOR FURTHER HERNIA SURGERY (FHS) WAS ALSO ASSESSED IN RELATION TO LONG-TERM SURVIVAL. THIS IS A RETROSPECTIVE COHORT STUDY WITH A SINGLE PROSPECTIVE FOLLOW-UP TIME-POINT NESTED IN A CONSECUTIVE SERIES OF PATIENTS UNDERGOING CAWR IN 2 EUROPEAN NATIONAL INTESTINAL FAILURE CENTERS. THE STUDY INCLUDED 254 PATIENTS (160 MALE AND 94 FEMALE PATIENTS; AGE: 58.0[SD 13.6]). DURING THE SURGICAL PROCEDURE, CHOICE OF MESH TYPE WAS TAILORED TO THE INDIVIDUAL PATIENT BUT BASED ON SOME BASIC PRINCIPLES. CHOICE OF MESH WERE VICRYL MESH (ETHICON), VYPRO MESH (ETHICON), ULTRAPRO MESH (ETHICON), PHYSIOMESH (ETHICON), PROCEED MESH (ETHICON), PROLENE MESH (ETHICON). IF FASCIAL CLOSURE WAS NOT ACHIEVABLE, THE DEFECT WAS BRIDGED USING AN INTRA-ABDOMINAL OR RETRO-MUSCULAR MESH OR BOTH. PASSIVE INTRA-ABDOMINAL DRAINS WERE USED WHERE DEEMED APPROPRIATE BUT NOT ROUTINELY, AND ACTIVE SUBCUTANEOUS DRAINS WERE USED ROUTINELY. DRAINS WERE REMOVED WHEN OUTPUT WAS BELOW 30 ML/24 H. NO SKIN GRAFTS WERE USED TO ACHIEVE PRIMARY SKIN CLOSURE. AMSTERDAM UNIVERSITY MEDICAL CENTRES (AUMC) PREFERRED INTERRUPTED POLYESTER MERSILENE SUTURE (ETHICON), WHEREAS ST MARKS HOSPITAL (SMH) TENDED TO USE SURGICAL CLIPS OR INTERRUPTED PROLENE SUTURES (ETHICON). IF A PLASTIC SURGEON WAS INVOLVED LAYERED CLOSURE WAS PERFORMED WITH ABSORBABLE SUTURES SUBCUTANEOUS. REPORTED COMPLICATIONS INCLUDED ENTEROCUTANEOUS FISTULA WITH INFECTED MESH (N-?), ENTEROCUTANEOUS FISTULA WITHOUT INFECTED MESH (N-?), INFECTED MESH (N-?), VIOLATION OF THE GI TRACT (N-?), STOMA PRESENT (N-?), OTHERS (N-?), HERNIA RECURRENCE (N-?) WHICH REQUIRED ADDITIONAL/FURTHER SURGERY. IT WAS REPORTED THAT THE PRESENT STUDY SHOWS THAT, ALTHOUGH OVERALL HERNIA RECURRENCE RATES AFTER CONTAMINATED CAWR ARE HIGH, THE MAJORITY OF PATIENTS DO NOT NEED TO UNDERGO FURTHER SURGERY, WITH AN 80% 5-YEAR OVERALL SURVIVAL RATE. IN THIS STUDY OF CONTAMINATED CAWR, NON-CROSSLINKED BIOLOGIC MESH SHOWS BETTER RESULTS THAN SYNTHETIC MESH. BRIDGING REPAIRS WITH NO POSTERIOR AND/OR ANTERIOR FASCIAL CLOSURE HAVE A HIGHER RECURRENCE RATE. THE OVERALL SURVIVAL WAS GOOD AND THE MAJORITY OF PATIENTS REMAINED FREE OF ADDITIONAL HERNIA SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156359 ULTRAPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention