BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 16102555 · Received January 5, 2023

    Report

    Report Number
    2210968-2023-00090
    Event Type
    Injury
    Date Received
    January 5, 2023
    Date of Event
    May 12, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HTTPS://DOI.ORG/10.1007/S10151-021-02455-2.

    Description of Event or Problem · 0

    TITLE: NON-DYNAMIC GRACILOPLASTY IS AN EFFECTIVE TREATMENT FOR PATIENTS WITH PASSIVE FECAL INCONTINENCE. THE AIM OF THIS STUDY WAS TO ASSESS THE EFFECTIVENESS AND SAFETY OF NON-DYNAMIC GRACILOPLASTY IN THIS SPECIFIC PATIENT COHORT. FROM NOVEMBER 2015 UNTIL JUNE 2018, A TOTAL OF 39 GRACILOPLASTIES WERE PERFORMED FOR VARIOUS REASONS. WE RETROSPECTIVELY STUDIED THE CHARTS OF ALL PATIENTS RECEIVING A NONDYNAMIC GRACILOPLASTY FOR COMPLAINTS OF PASSIVE FI. PASSIVE FECAL LOSS WAS DEFINED AS INCONTINENCE OF SOLID FECES WITHOUT HAVING HAD AN URGE TO DEFECATE AND URGE INCONTINENCE WAS DEFINED AS FECAL LOSS DESPITE AN URGE TO DEFECATE. THE GRACILIS MUSCLE WAS TRANSPOSITIONED AROUND THE ANUS AND FIXATED TO THE PERIOSTEUM OF THE TRANSITION ZONE BETWEEN THE PUBIC AND ISCHIAL BONE WITH TWO MERSILENE SUTURES ETHICON. REPORTED COMPLICATIONS INCLUDED PASSIVE FECAL INCONTINENCE (N=31), IN 3 MONTHS (N=8), IN 6 MONTHS (N=4), IN 12 MONTHS (N=2), URGE INCONTINENCE (N= 26), I N 3 MONTHS (N=5), IN 6 MONTHS (N=7), IN 12 MONTHS (N=4) SURGICAL-SITE INFECTION (N=2), PROCTITIS (N=1), CONSTIPATION(N=8), RECTAL PERFORATION (N=1), RECTOVAGINAL FISTULA (N=1), URINARY RETENTION (N=5). IN CONCLUSION NON-DYNAMIC GRACILOPLASTY IS AN EFFECTIVE TREATMENT FOR PASSIVE FECAL INCONTINENCE. DIFFERENTIATION BASED ON SUBTYPES OF FECAL INCONTINENCE MIGHT BE IMPORTANT FOR A PATTERN-SPECIFIC APPROACH TO TREATMENT. MORE RESEARCH IS NECESSARY TO DETERMINE THE RIGHT INDICATIONS FOR MORE INVASIVE TREATMENTS OF FECAL INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644458 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention