BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 23178519 · Received September 30, 2025

    Report

    Report Number
    2210968-2025-11177
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    June 18, 2024
    Report Date
    September 30, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: J AYUB MED COLL ABBOTTABAD. 2024 APR-JUN;36(2):380-382. DOI: 10.55519/JAMC-02-13427. PMID: 39609985. HTTPS://DOI.ORG/10.55519/JAMC-02-13427.

    Description of Event or Problem · 0

    A COMPARATIVE STUDY OF VICRYL RAPIDE SUTURE VERSUS CHROMIC CATGUT SUTURE FOR EPISIOTOMY REPAIR. THE AIM OF THIS STUDY IS TO DETERMINE PAIN AT 48 HOURS AND ANALGESIA REQUIREMENT AT 7TH DAY BETWEEN VICRYL RAPIDE SUTURE AND CHROMIC CATGUT SUTURE. WRITTEN CONSENT WAS OBTAINED FROM ALL THE PATIENTS WHO DELIVERED IN OUR HOSPITAL AND REQUIRED EPISIOTOMY. AGE 18¿35 YEARS. ANY PARITY. FEMALE REQUIRING EPISIOTOMIES FOLLOWING SPONTANEOUS OR INSTRUMENTAL DELIVERIES (AS PER OPERATIONAL DEFINITION). A NON-PROBABILITY, CONSECUTIVE SAMPLING TECHNIQUE WAS APPLIED TO DIVIDE 206 STUDY PARTICIPANTS IN TWO GROUPS, I.E., (N=103) IN VICRYL RAPIDE (GROUP A) AND (N=103) IN CHROMIC CATGUT (GROUP B). REPORTED COMPLICATIONS ARE: VICRYL RAPIDE SUTURE (ETHICON) - PAIN AT 48 HOURS (N=33) TREATMENT: NOT REPORTED - UNKNOWN EVENT (N=2) TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD ANALGESIA REQUIREMENT AT 7TH DAY WITH UNKNOWN CAUSE CHROMIC CATGUT SUTURE (ETHICON) - PAIN AT 48 HOURS (N=52) TREATMENT: NOT REPORTED - UNKNOWN EVENT (N=26) TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD ANALGESIA REQUIREMENT AT 7TH DAY WITH UNKNOWN CAUSE IN CONCLUSION, THIS STUDY CONCLUDED THAT VICRYL RAPIDE WAS THE BEST SUTURE MATERIAL FOR EPISIOTOMY REPAIR, RESULTING IN DECREASED PAIN AFTER 48 HOURS AND LESSER NEED FOR ANALGESIA BY THE SEVENTH DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672480 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention