BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19031527 · Received April 3, 2024

    Report

    Report Number
    2210968-2024-03788
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    July 19, 2022
    Report Date
    April 3, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    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: INT J ACAD MED PHARM,2022; 4 (3); 251-255. HTTPS://DOI.ORG/10.47009/JAMP.2022.4.3.57. PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE: COMPARATIVE STUDY OF PRIMARY ASARP WITH STAGED ASARP WITH PROTECTIVE COLOSTOMY, IN FEMALE PATIENTS WITH VESTIBULAR FISTULAS. THE AIM IS TO DESIGN A SELECTION CRITERION TO CHOOSE PRIMARY ASARP OR STAGED REPAIR WITH PROTECTIVE COLOSTOMY AND ASARP IN FEMALES WITH LOW ANORECTAL MALFORMATION BY COMPARING THE RESULTS IN BOTH APPROACHES. FROM DECEMBER 2015 TO NOVEMBER 2017, 30 CASES OF FEMALE LOW ANORECTAL MALFORMATION VESTIBULAR FISTULAS WERE INCLUDED IN THE STUDY. PRIMARY ASARP WAS PERFORMED IN 20 PATIENTS AND STAGED ASARP IN 10 PATIENTS. IN PRIMARY ASARP VESTIBULAR FISTULA IN 8 CASES WERE NEONATES; 3 CASES WERE INFANTS AND 1 CASE IS OF >1YEAR, ANTERIORLY PLACED ANUS OR ECTOPIC ANUS IN ALL 8 CASES ARE INFANTS. IN STAGED ASARP VESTIBULAR FISTULA IN 4 CASES WERE NEONATES AND 3 CASES WERE INFANTS. ANTERIORLY PLACED ANUS OR ECTOPIC ANUS IN 2 CASES ARE INFANTS AND 1 CASE >1YEAR AGE. IN PRIMARY PROCEDURE, VAGINAL TRAUMA OCCURRED IN 4 CASES AND RECTAL TRAUMA IN 2 CASES AND BOTH INJURIES WERE REPAIRED WITH 4-0 VICRYL SUTURES (ETHICON). REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N=3) AND WOUND DEHISCENCE (N=2). IN CONCLUSION, PRIMARY ASARP IS SIMPLE ONE STAGE PROCEDURE FOR LOW ANORECTAL MALFORMATION IN FEMALES IRRESPECTIVE OF AGE AT PRESENTATION, INCLUDING THE NEWBORN BABIES IF SELECTED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545714 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention