BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 12602035 · Received October 9, 2021

    Report

    Report Number
    1219930-2021-04194
    Event Type
    Injury
    Date Received
    October 9, 2021
    Date of Event
    February 14, 2021
    Report Date
    October 8, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: PREVALENCE AND PREDICTORS OF POSTOPERATIVE DETRUSOR UNDERACTIVITY AFTER ROBOT-ASSISTED RADICAL PROSTATECTOMY: A PROSPECTIVE OBSERVATIONAL STUDY. SOURCE: INTERNATIONAL JOURNAL OF UROLOGY (2021) 28, 734-740 ONLINE PUBLICATION 20 MARCH 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN MAY 2013 AND AUGUST 2014, WHICH EVALUATED THE POSTOPERATIVE DETRUSOR UNDERACTIVITY IN PATIENTS WHO UNDERWENT ROBOT-ASSISTED RADICAL PROSTATECTOMY. IN ALL CASES, A SUTURE WAS USED FOR THE ANASTOMOSIS BETWEEN THE URETHRA AND BLADDER. FIVE PATIENTS WERE EXCLUDED FROM THE STUDY DUE TO POSTOPERATIVE COMPLICATIONS: URETHRAL STRICTURE ON 2 PATIENTS, ANASTOMOTIC LEAKAGE ON 1 PATIENT, ILEUS ON 1 PATIENT AND BLEEDING ON 1 PATIENT. THERE WERE NO INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500107 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other