BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 14434071 · Received May 19, 2022

    Report

    Report Number
    2210968-2022-03841
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    December 1, 2020
    Report Date
    May 18, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 (MONOCRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS (MONOCRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE DEATH DESCRIBED IN THE ARTICLE? 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. 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: PLAST. RECONSTR. SURG. (2020); 146: 777E-789E. HTTPS://DOI.ORG/10.1097/PRS.0000000000007356.

    Description of Event or Problem · 0

    TITLE: A NOVEL ABSORBABLE STAPLER PROVIDES PATIENT-REPORTED OUTCOMES AND COST-EFFECTIVENESS NONINFERIOR TO SUBCUTICULAR SKIN CLOSURE: A PROSPECTIVE, SINGLE-BLIND, RANDOMIZED CLINICAL TRIAL. THE AIM OF THIS PROSPECTIVE, PATIENT SINGLE-BLIND, RANDOMIZED, TWO-ARM, PARALLEL-GROUP, MULTICENTER, NONINFERIORITY STUDY IN 26 FRENCH HOSPITALS WAS TO CONFIRM THE DEVICE¿S EFFECTIVENESS AS THE PRIMARY ENDPOINT, IN ADDITION TO ITS SAFETY (FOR BOTH THE SURGEON AND THE PATIENT), TOLERABILITY, TIME SAVINGS (THE OVERALL OPERATING TIME AND THE DURATION OF ANESTHESIA), DIRECT PATIENT BENEFITS, AND ITS COST-EFFECTIVENESS RELATIVE TO CONVENTIONAL SUTURING. FROM MARCH OF 2012 TO MARCH OF 2013, A TOTAL OF 660 PATIENTS WERE RANDOMIZED, AND 649 CONSTITUTED THE FULL ANALYSIS [STAPLER ARM, N = 324 (118 MALE AND 206 FEMALE; MEAN AGE OF 49.6 ± 13.3 YEARS; NEEDLE ARM, N = 325; 108 MALE AND 217 FEMALE; MEAN AGE OF 49.0 ± 13.1 YEARS]. PATIENTS UNDERWENT ELECTIVE SURGERY FOR ABDOMINOPLASTY, CERVICOTOMY, OR SUPRAPUBIC SURGERY. SURGERY WAS PERFORMED USING A COMPETITOR DEVICE IN STAPLER ARM AND MONOCRYL SUTURE (ETHICON) IN NEEDLE ARM. THE TOTAL STUDY DURATION WAS 2.5 YEARS, WITH A 1-YEAR ENROLLMENT PERIOD AND AN 18-MONTH FOLLOW-UP PERIOD. REPORTED COMPLICATIONS INCLUDE SUTURE-RELATED COMPLICATIONS (N=11) REQUIRING CONSULTATIONS, INFECTIONS AND INFESTATIONS (N=14), INJURY, POISONING, AND PROCEDURAL COMPLICATIONS (N=40), PRODUCT ISSUES (N=20), SKIN AND SUBCUTANEOUS TISSUE DISORDERS (N=2), SURGICAL AND MEDICAL PROCEDURES (N=1), VASCULAR DISORDERS (N=5), SUTURING-RELATED OCCUPATIONAL EXPOSURE TO BLOOD INVOLVING SURGICAL STAFF (N=2.1%). IN CONCLUSION, USE OF A SEMIAUTOMATIC STAPLER FOR DEEP DERMAL SUTURING IN GYNECOLOGIC; EAR, NOSE, AND THROAT; AND PLASTIC SURGERY IN FRENCH UNIVERSITY HOSPITALS PROVIDED WOUND HEALING OUTCOMES THAT WERE NOT WORSE THAN WITH CONVENTIONAL SUTURING. THE USE OF THIS NEW DEVICE IS ASSOCIATED WITH A NONINFERIORITY FOR OUTCOMES AND TIME, A MINIMALLY HIGHER COST. HIGHER SAFETY SHOULD BE FURTHER CONFIRMED IN LARGER STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2094413 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention