BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7575431 · Received June 6, 2018

    Report

    Report Number
    2210968-2018-73336
    Event Type
    Injury
    Date Received
    June 6, 2018
    Report Date
    May 16, 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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS 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. DOES THE SURGEON BELIEVE THAT 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 THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: ARCH. ESP. UROL. 2016; 69 (1): 32-37. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: INFLUENCE OF BARBED SUTURE IN LAPAROSCOPIC RADICAL PROSTATECTOMY AUTHORS: MARCOS CEPEDA, BEATRIZ DE LA CRUZ, JOSÉ H. AMÓN, CONSUELO CONDE, MANUEL RUIZ AND JOSÉ MARÍA MARTÍNEZ-SAGARRA. CITATION: ARCH. ESP. UROL. 2016; 69 (1): 32-37 THIS RETROSPECTIVE STUDY AIMED TO DETERMINE THE INFLUENCE OF BARBED SUTURE IN LAPAROSCOPIC RADICAL PROSTECTOMY. BETWEEN JAN2013 AND DEC2014, 150 PATIENTS WHO UNDERGONE LAPAROSCOPIC RADICAL PROSTECTOMY WERE INCLUDED AND DIVIDED INTO TWO GROUPS ACCORDING TO THE TYPE OF SUTURE EMPLOYED FOR URETHROVESICAL ANASTOMOSIS (UVA): GROUP 1 (N=70) UTILIZED VICRYL SUTURES AND GROUP 2 (N=80) UTILIZED QUIL PDO (BARBED SUTURE). THE PROCEDURE WAS PERFORMED ON BOTH GROUPS IN A SIMILAR FASHION EXCEPT FOR THE UVA. IN GROUP 1 WHERE VICRYL WAS USED IN UVA, 10 PATIENTS DEVELOPED URINARY FISTULA FROM THIRD POSTOPERATIVE DAY ONWARDS. THE TREATMENT OF THE EVENTS WAS NOT REPORTED. STATISTICAL SIGNIFICANT DIFFERENCES WERE FOUND BETWEEN GROUPS REGARDING POSTOPERATIVE URINARY FISTULA RATE, FAVORABLE TO GROUP 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418186 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention