BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    MDR report key: 20352721 · Received October 2, 2024

    Report

    Report Number
    2210968-2024-10475
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    July 1, 2024
    Report Date
    October 2, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: WANG DONG-MEI & ZHU XIAO-RONG, VALUE OF HEART-SHAPED COSMETIC SUTURE AND MODIFIED SKIN SUTURE ON REDUCING ABDOMINAL SCAR FORMATION DURING CESAREAN SECTION (2024), JOURNAL OF MEDICAL INFORMATION VOL. 37, NO.13, JUL. 2024. PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE: VALUE OF HEART-SHAPED COSMETIC SUTURE AND MODIFIED SKIN SUTURE ON REDUCING ABDOMINAL SCAR FORMATION DURING CESAREAN SECTION. BODY: IN THIS STUDY, THE VALUE OF HEART-SHAPED COSMETIC SUTURE AND SKIN MODIFIED SUTURE IN REDUCING ABDOMINAL SCAR FORMATION BY CESAREAN SECTION WAS OBSERVED, AND REPORTED. BETWEEN JANUARY 2021 TO JANUARY 2023, 60 PATIENTS WITH A MEAN AGE OF 31.9 YEARS WERE SELECTED AS SUBJECT IN THE STUDY AND WAS DIVIDED INTO TWO GROUPS. THE CONTROL GROUP WITH 30 PATIENTS USING A VICRYL PLUS SUTURE, AND THE OBSERVATIONAL GROUP WITH 30 PATIENTS USING A HEART-SHAPED COSMETIC SUTURE AND MODIFIED SKIN SUTURE. REPORTED COMPLICATIONS INCLUDE: (N=6) INCIDENCE OF SCAR HYPERPLASIA, (N=3) JOINT STIFFNESS, (N=1) INFECTION, AND (N=1) READHESIONS FROM THE CONTROL GROUP. CONCLUSION: HEART-SHAPED COSMETIC SUTURE AND MODIFIED SKIN SUTURE CAN REDUCE ABDOMINAL SCAR FORMATION, SHORTEN INCISION SUTURE AND HEALING TIME, REDUCE POSTOPERATIVE PAIN SCORE, IMPROVE VSS SCORE, IMPROVE SCAR HEALING DEGREE, AND REDUCE THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS IN CESAREAN SECTION, WHICH HAS IDEAL APPLICATION VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35712 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other