BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 15051047 · Received July 19, 2022

    Report

    Report Number
    2210968-2022-05631
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    September 8, 2021
    Report Date
    July 19, 2022
    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? 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. 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: KATIYAR ET AL.AFR J UROL (2021) 27:127; HTTPS://DOI.ORG/10.1186/S 12301-021-00231-0.

    Description of Event or Problem · 0

    TITLE: URETHRAL MEATUS PRESERVING VENTRAL ONLAY AUGMENTATION URETHROPLASTY FOR FEMALE URETHRAL STRICTURE: OUR TECHNIQUE WITH INITIAL EXPERIENCE. THIS STUDY DESCRIBES THE TECHNIQUE OF URETHRAL MEATUS SPARING VENTRAL ON LAY MUCOSAI GRAFT AUGMENTATION URETHROPLASTY WITH THE AUTHORS¿ INITIAL EXPERIENCE. BETWEEN SEPTEMBER 2017 AND OCTOBER 2019, 10 PATIENTS DIAGNOSED WITH FEMALE URETHRAL STRICTURE WITH NORMAL URETHRAL MEATUS WHO UNDERWENT MEATUS SPARING URETHROPLASTY WERE INCLUDED IN THE STUDY. THE AVERAGE AGE OF PATIENTS WAS 48 ± 10.80 YEARS (RANGE 35-63). ALL PATIENTS UNDERWENT VENTRAL ONLAY URETHROPLASTY. BUCCAL OR VAGINAL MUCOSAL GRAFT WERE USED FOR THE PURPOSE OF RECONSTRUCTION. PARAURETHRAL TISSUE FLAP CLOSURE WAS DONE TRANSVERSELY OVER THE URETHRA BY CONTINUOUS VICRYL 4- 0 SUTURE (ETHICON). EACH SUTURE TOOK PARAURETHRAL TISSUE FLAP ON EITHER SIDE AND GRAFT TISSUE MEDIALLY, THUS DOING EXTERNAL QUILTING OF MUCOSAL GRAFT TO PARAURETHRAL TISSUE LAYER. THE ANTERIOR VAGINAL WALL WAS CLOSED BY CONTINUOUS VICRYL 3-0 SUTURE (ETHICON). PATIENTS WERE DISCHARGED BY POSTOPERATIVE DAY 3 AND CATHETER WAS REMOVED 3 WEEKS POST-SURGERY IN ALL OF PATIENTS. THE REPORTED COMPLICATION INCLUDED RECURRENT SHORT SEGMENT NARROWING OF URETHRAL LUMEN AT PROXIMAL ANASTOMOTIC JUNCTION OF URETHRAL MUCOSA AND THE GRAFTED MUCOSA (N=1). IN CONCLUSION, THE TECHNIQUE OF MEATUS SPARING VENTRAL ON LAY AUGMENTATION GRAFT URETHROPLASTY IS A PROMISING APPROACH WITH GOOD OUTCOMES, IS REPRODUCIBLE AND HAS MINIMAL COMPLICATION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698030 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention