BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 11446769 · Received March 9, 2021

    Report

    Report Number
    2210968-2021-02145
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    April 1, 2015
    Report Date
    February 26, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. CITATION: JOURNAL OF UROLOGY. 2015 APR; CONFERENCE: 2015 ANNUAL MEETING OF THE AMERICAN UROLOGICAL ASSOCIATION, AUA. NEW ORLEANS, LA UNITED STATES. CONFERENCE PUBLICATION: (VAR.PAGINGS). 193 (4 SUPPL. 1) :E471-E472.

    Description of Event or Problem · 1

    TITLE: LAPAROSCOPIC INTRA-ABDOMINAL PATENT PROCESS VAGINALIS LIGATION IN PEDIATRIC UROLOGY PRACTICE AUTHOR: BARADARAN N., WOOD C., PRASAD M., STEC A. THIS STUDY PRESENTS THE AUTHORS¿ EXPERIENCE, OUTCOMES AND COMPLICATIONS USING LAPAROSCOPIC INTRAABDOMINAL PATENT PROCESS VAGINALIS LIGATION (LIPPL). BETWEEN 2012 AND 2014, 84 PATIENTS (1 FEMALE) WITH MEDIAN AGE OF 24 (1-216) MONTHS UNDERWENT LIPPL. THE PATENT PROCESSUS VAGINALIS (PPV) IS IDENTIFIED AND INTERNAL RING IS LIGATED USING PERCUTANEOUS INSERTION OF SPINAL NEEDLE ABOVE THE INTERNAL RING. THE NEEDLE IS PASSED LATERALLY AND A LOOP OF A 2-0 OR 3-0 PROLENE SUTURE (ETHICON) IS PASSED INTO THE ABDOMEN. THE NEEDLE IS WITHDRAWN, REINSERTED AND A TAIL OF THE SUTURE IS PASSED INTO THE ABDOMEN. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. DURING FOLLOW-UP, PATIENTS HAD RESIDUAL NON-COMMUNICATION HYDROCELES (N=2), SUTURE GRANULOMA REQUIRING EXCISION (N=1) AND A MINOR TESTICULAR ASCENT (N=1). THE LIPPL TECHNIQUE ADHERES TO THE SAME PRINCIPLES OF OPEN INGUINAL HERNIA REPAIR BY LIGATING THE OPEN INTERNAL RING. THIS OUTPATIENT PROCEDURE HAS A LOW COMPLICATION RATE AND MINIMAL RISK OF RECURRENCE. IT PROVIDES PATIENTS WITH THE BENEFITS OF LAPAROSCOPIC SURGERY INCLUDING ABILITY TO EVALUATE THE CONTRALATERAL INGUINAL RING, BARELY VISIBLE SCARS, AND SHORT RECOVERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340706 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention