BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9974980 · Received April 17, 2020

    Report

    Report Number
    2210968-2020-03193
    Event Type
    Injury
    Date Received
    April 17, 2020
    Report Date
    March 25, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY (2019) 26, 1282-1287; 2018 AAGL; DOI: HTTPS://DOI.ORG/10.1016/J.JMIG.2018.12.007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: MORBIDITY OF A SINGLE INCISION TRANSVAGINAL MESH TO CORRECT APICAL PROLAPSE". AUTHORS: STEPHEN T. JEFFERY, MD; BRITA S. KORTZ, BD; DAKALO MUAVHA, MD; NINA N. STOLWIJK, BD; LAMEES RAS, MD; AND JAN-PAUL W.R. ROOVERS, MD, PHD. CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY (2019) 26, 1282-1287; 2018 AAGL; DOI: HTTPS://DOI.ORG/10.1016/J.JMIG.2018.12.007. THIS RETROSPECTIVE STUDY AIMED TO DETERMINE COMPLICATIONS AND RELATED REINTERVENTION RATES ASSOCIATED WITH USE OF THE UPHOLD VAGINAL SUPPORT SYSTEM FOR SYMPTOMATIC VAGINAL APICAL PROLAPSE. BETWEEN 2012 AND 2017, 59 PATIENTS (MEAN AGE=67 ± 9.3 YEARS, AGE RANGE=43 ¿ 91 YEARS) WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, THE DISTAL PART OF THE MESH WAS SUTURED TO THE BLADDER NECK WITH 2 VICRYL 2/0 SUTURES (ETHICON) 1 CM RIGHT AND LEFT OF THE MIDLINE. VICRYL 2/0 WAS USED TO CLOSE THE VAGINAL INCISION. REPORTED COMPLICATIONS INCLUDED BLADDER INJURY (N=1); URINARY TRACT INFECTION (N=5); INCOMPLETE BLADDER EMPTYING (N=16) FOLLOWING REMOVAL OF THE CATHETER ON THE FIRST POSTOPERATIVE DAY, AND 9 PATIENTS LEFT THE HOSPITAL WITH A CATHETER IN PLACE. IN ALL OF THESE WOMEN, BLADDER EMPTYING NORMALIZED OVER TIME. ONE PATIENT NEEDED A SUPRAPUBIC CATHETER FOR 26 DAYS UNTIL BLADDER EMPTYING NORMALIZED. THIS PATIENT ALSO REQUIRED SURGICAL LOOSENING OF AN MIDURETHRAL SLING (MUS) THAT HAD BEEN PLACED CONCOMITANTLY; VAGINAL HEMATOMA (N=1); DE NOVO STRESS URINARY INCONTINENCE (N=2) WHICH REQUIRED MUS. IN CONCLUSION, USE OF THE UPHOLD VAGINAL SUPPORT SYSTEM FOR SYMPTOMATIC VAGINAL APICAL PROLAPSE WAS ASSOCIATED WITH A SIGNIFICANT RISK OF OBSTRUCTED MICTURITION. IN OUR STUDY POPULATION, 15% REQUIRED REPEAT SURGERY, MAINLY FOR RECURRENT PELVIC ORGAN PROLAPSE AND DE NOVO STRESS URINARY INCONTINENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435954 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention