BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 18392582 · Received December 26, 2023

    Report

    Report Number
    2210968-2023-10126
    Event Type
    Injury
    Date Received
    December 26, 2023
    Date of Event
    June 23, 2023
    Report Date
    December 26, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. CITATION: HTTPS://DOI.ORG/10.12688/F1000RESEARCH.126555.2.

    Description of Event or Problem · 0

    TITLE: CLINICAL EQUIVALENCE OF TRUSYNTH FAST® AND VICRYL RAPIDE ® POLYGLACTIN 910 FAST ABSORBING SUTURES ON MATERNAL MORBIDITY EXPERIENCED BY WOMEN FOLLOWING EPISIOTOMY REPAIR: A SINGLE-BLIND, RANDOMIZED STUDY THE OBJECTIVE OF THIS STUDY IS FOR SUBJECTIVE ASSESSMENT OF PERINEAL PAIN POST-EPISIOTOMY REPAIR, WITH TRUSYNTH FAST® AND VICRYL RAPIDE® POLYGLACTIN 910 FAST-ABSORBING SUTURES. BETWEEN (B)(6) 2021, A TOTAL OF 100 WOMEN WERE SCREENED FOR ELIGIBILTY. HOWEVER, 96 SUBJECTS (WOMEN AGED 18-40 YEARS OLD), WHO RECEIVED THE ALLOCATED INTERVENTION (TRUSYNTH FAST,N=47; AND VICRYL RAPIDE,N=49) FOR EPISIOTOMY REPAIR. IN THE VICRYL RAPIDE ® GROUP, ONE SUBJECT HAD GENERAL BODY PAINS ALONG WITH VOMITING AND HEADACHE, ONE SUBJECT HAD FEVER, ONE SUBJECT HAD GENERAL BODY PAINS, AND ONE SUBJECT HAD VOMITING. THE ADVERSE EVENTS WERE MILD IN SEVERITY AND NOT RELATED TO THE STUDY DEVICE. THE PRESCRIBED/CONCOMITANT MEDICATIONS USED DURING THE STUDY PERIOD ARE GIVEN. PRIMIPAROUS OR MULTIPAROUS WOMEN (18-40 YEARS), WHO REQUIRED EPISIOTOMY DURING VAGINAL DELIVERY WERE INCLUDED, AND EITHER TRUSYNTH FAST® (N=47) OR VICRYL RAPIDE® (N=49) SUTURE WAS USED FOR THEIR EPISIOTOMY REPAIR. REPORTED COMPLICATIONS INCLUDED SWELLING (N=15), GENERAL BODY PAINS ALONG WITH VOMITING AND HEADACHE (N=1), FEVER (N=1), GENERAL BODY PAINS (N=1), AND VOMITING (N=1). IN CONCLUSION, TRUSYNTH FAST® SUTURE IS CLINICALLY EQUIVALENT TO VICRYL RAPIDE® SUTURE AND CAN BE USED FOR EPISIOTOMY REPAIR WITH MINIMAL RISK OF PERINEA I PAIN AND WOUND COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2265791 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention