BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12569361 · Received October 4, 2021

    Report

    Report Number
    2210968-2021-09139
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    August 12, 2020
    Report Date
    September 14, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS 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. 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: ANNALS OF MEDICINE AND SURGERY 57 (2020) 291¿294.

    Description of Event or Problem · 1

    TITLE: SAFETY AND EFFICACY OF THE TREATMENT OF CHRONIC ANAL FISSURE BY LATERAL INTERNAL SPHINCTEROTOMY: A RETROSPECTIVE COHORT STUDY THE PRIMARY OBJECTIVE OF THIS STUDY IS TO UNDERSTAND THE SAFETY AND EFFECTIVENESS OF THE LATERAL INTERNAL ANAL SPHINCTEROTOMY (LIS) FOR THE TREATMENT OF CHRONIC ANAL FISSURE IN A COHORT OF PATIENTS. FROM APRIL 2004 TO APRIL 2020, A TOTAL OF 691 FEMALE PATIENTS WITH AN AVERAGE AGE OF 45.77 YEARS (RANGING FROM 17 TO 82 YEARS) UNDERWENT LATERAL INTERNAL SPHINCTEROTOMY (LIS) SURGICAL PROCEDURE FOR THE TREATMENT OF CHRONIC ANAL FISSURE. THE WOUND WAS CLOSED USING VICRYL 3-0 SUTURE AND A SMALL DRESSING WAS APPLIED AT END OF PROCEDURE. ANORECTAL EXAMINATION OF THE PATIENTS WAS PERFORMED IN EVERY FOLLOW-UP CLINIC VISIT, AND THE FISSURE HEALING WAS MONITORED; THE POSTOPERATIVE FOLLOW-UP VISITS WERE SCHEDULED AFTER 1 WEEK, THEN AFTER 2 WEEKS, 4 WEEKS, AND 8 WEEKS, RESPECTIVELY. PAIN RELIEF WAS ASSESSED USING A VISUAL ANALOG SCALE REPRESENTING THE SEVERITY OF PAIN FROM 0 (NO PAIN) TO 10 (WORST IMAGINABLE PAIN). (N=55) DID NOT OBSERVE ANY RELIEF IN PAIN, EVEN AT THE END OF THE EIGHTH WEEK (N=2) PERINEAL ABSCESS. RELIEVED OF THE PROBLEMS AFTER DRAINAGE OF THE ABSCESS (N=1) PERINEAL HEMATOMA, AND THAT PATIENT USED ANTICOAGULANTS. RELIEVED OF THE PROBLEMS AFTER CONTROL OF BLEEDING FROM A HEMATOMA (N=2) RECURRENCE OF ANAL FISSURE WHICH IMPROVED WITH TIME, AND REGRESSED IN THE FOURTH POSTOPERATIVE MONTH. THE PATIENTS WHO HAD A RECURRENCE ALSO HAD A HISTORY OF PREVIOUS SURGERY. THE FEMALE WITH INCONTINENCE WAS ELDERLY, AND ONE PATIENT HAD MULTIPLE VAGINAL DELIVERIES. (N=3 ) DEVELOPED INCONTINENCE FOR GAS WHICH IMPROVED WITH TIME, AND REGRESSED IN THE FOURTH POSTOPERATIVE MONTH THIS STUDY REPORTS THAT LATERAL INTERNAL SPHINCTEROTOMY (LIS) IS A SAFE SURGICAL TREATMENT FOR CHRONIC ANAL FISSURE, LEADING TO A REDUCTION IN RECURRENCE, INCONTINENCE RATE AND SUBSTANTIALLY IMPROVES SYMPTOMS, ESPECIALLY PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468541 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention