BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7375212 · Received March 27, 2018

    Report

    Report Number
    2210968-2018-71690
    Event Type
    Injury
    Date Received
    March 27, 2018
    Report Date
    March 6, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 ANY DEFICIENCY OF THE ETHICON PRODUCT VICRYL SUTURE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? CITATION: EUR SURG (2016) 48:47¿50; DOI 10.1007/S10353-015-0353-5. (B)(4)

    Description of Event or Problem · 1

    TITLE: VESICOVAGINAL FISTULAS: TRANSPERITONEAL SURGICAL REPAIR USING OMENTUM OR PERITONEAL TISSUE INTERPOSITION, A SUMMARY OF 35 YEARS OF EXPERIENCE. IT WAS REPORTED IN A JOURNAL ARTICLE: THE AIM OF THIS RETROSPECTIVE STUDY WAS TO REPORT THE RESULT OF PRIMARY VESICOVAGINAL FISTULA REPAIR USING THE TRANSABDOMINAL APPROACH WITH OMENTAL OR PERITONEAL FLAP INTERPOSITION. FROM 1978 TO 2002, 38 PATIENTS WITH VESICOVAGINAL FISTULA UNDERWENT REPAIR USING TRANSABDOMINAL APPROACH WITH OMENTAL (N=32) OR PERITONEAL FLAP (N=6) WERE INCLUDED IN THE STUDY. INTERRUPTED VICRYL-0 SUTURES WERE USED IN VAGINAL WALL AND BLADDER WALL. A RUNNING VICRYL 1-0 WAS USED IN CLOSURE OF POSTERIOR BLADDER WALL. OVERALL, 4 PATIENTS HAD RECURRENCE OF THE FISTULA ALL WITH PRIMARY PERITONEAL FLAP INTERPOSITION. TWO OF THE PATIENTS WERE SUCCESSFULLY TREATED WITH PERITONEAL FLAP RE-INTERPOSITION, WHILE THE OTHER TWO, SIGMA RECTUM POUCH WAS PERFORMED. ALSO, COMPLICATIONS INCLUDED WOUND INFECTION (N=2) AND TRANSIENT URINARY INCONTINENCE (N=5) WHICH STOPPED SPONTANEOUSLY. TRANSPERITONEAL SURGICAL REPAIR USING OMENTUM OR PERITONEAL TISSUE INTERPOSITION SHOULD BE CONSIDERED IN THE FIRST ATTEMPT OF REPAIR OF SUPRATRIGONAL VESICOVAGINAL FISTULA. ADDITIONAL INFORMATION HAS BEEN REQUESTED .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216316 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention