BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 14988906 · Received July 12, 2022

    Report

    Report Number
    2210968-2022-05383
    Event Type
    Injury
    Date Received
    July 12, 2022
    Date of Event
    October 27, 2020
    Report Date
    July 12, 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

    (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. 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. RELATED EVENTS CAPTURED VIA 2210968-2022-05382. CITATION: APROSPECTIVE STUDY. UROL SCI 2020;31:206-10. DOI: 10.4103/UROS.UROS_63_20.

    Description of Event or Problem · 0

    TITLE: DORSOLATERAL ONLAY BUCCAL MUCOSAL URETHROPLASTY FOR ANTERIOR URETHRAL STRICTURES BY UNILATERAL URETHRAL MOBILIZATION: A PROSPECTIVE STUDY. THE PRESENT STUDY AIMED TO EVALUATE THE OUTCOMES OF BMG URETHROPLASTY BY DORSOLATERAL ONLAY TECHNIQUE IN PATIENTS WITH ANTERIOR URETHRAL STRICTURE. THIS WAS A PROSPECTIVE INTERVENTIONAL STUDY CONDUCTED AT THE DEPARTMENT OF UROLOGY AT PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH BETWEEN JANUARY 2015 AND DECEMBER 2018. A TOTAL OF 54 PATIENTS WHO UNDERWENT BMG URETHROPLASTY BY DORSOLATERAL ONLAY GRAFT WERE INCLUDED IN THIS STUDY. THE MEAN AGE OF THE PATIENTS WAS 54.16 YEARS (RANGE, 22-74 YEARS). THE RAW AREA OF THE CHEEK WAS APPROXIMATED USING 3-0 CHROMIC CATGUT WITH CONTINUOUS SUTURING. THE APPROXIMATE LENGTH OF THE DEFATTED BMG WAS SUTURED TO THE OPEN URETHRAL PLATE USING 4-0 VICRYL WITH CONTINUOUS SUTURES . REPORTED COMPLICATIONS INCLUDED ORAL CAVITY BLEEDING (N=2) , FACIAL PAIN AND SWELLING (N=4), RESTRICTION OF MOUTH OPENING (N=1), ORAL NUMBNESS (N=2) , SUPERFAICIAL WOUND INFECTION (N=2), URETHRAL STRICTURE RECURRENCE (N=8), MEATAL STENOSIS (N=2). IN CONCLUSION THE DORSOLATERAL ONLAY BMG BYUNILATERAL URETHRAL MOBILIZATION IS A SAFE AND FEASIBLE FORM OF GRAFT PLACEMENT WITH A REDUCED CHANCE OF GRAFT REJECTION AND POSTOPERATIVE COMPLICATIONS FOR ANTERIOR URETHRAL STRICTURES. BMG IS AN IDEAL SUBSTITUTE FOR THE URETHRA IN TREATING ANTERIOR URETHRAL STRICTURE WITH MINIMAL DONOR SITE MORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773578 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention