BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7450304 · Received April 23, 2018

    Report

    Report Number
    2210968-2018-72262
    Event Type
    Injury
    Date Received
    April 23, 2018
    Report Date
    March 28, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: OBESITY SURGERY, 14, 16-22. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: ANALYSIS OF THE INCIDENCE AND RISK FACTORS FOR WOUND INFECTIONS IN OPEN BARIATRIC SURGERY¿ AUTHOR: NICOLAS V. CHRISTOU, MD, PHD; JOYCE JARAND, RN; JEAN-LOUP SYLVESTRE, RN; ALEXANDER P.H. MCLEAN, MD WEB ADDRESS: DOI: 10.1053/J.JFAS.2004.07.006 CITATION: OBESITY SURGERY, 14, 16-22 THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE INCIDENCE AND RISK FACTORS FOR WOUND INFECTION IN OPEN BARIATRIC SURGERY. BETWEEN APRIL 1, 2001 TO MARCH 31, 2003, 269 PATIENTS, 219 WOMEN AND 50 MEN BETWEEN THE AGED OF 29 TO 49 WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, A PREVIOUSLY PLACED 32-FR BOUGIE WAS HELD AGAINST THE LESSER CURVE AND A 25-MM EEA® (ETHICON ENDOSURGERY) WAS USED TO CREATE A CIRCULAR OPENING INTO THE STOMACH. A ROUXLIMB OF JEJUNUM (100-300 CM LONG DEPENDING ON BMI) WAS BROUGHT UP IN A RETROCOLIC RETROGASTRIC FASHION, AND AN END-TO-SIDE GASTROJEJUNOSTOMY WAS FASHIONED USING A 3-0 PDS® (ETHICON ENDOSURGERY) SINGLE CONTINUOUS SUTURE AROUND AN 18-FR NASOGASTRIC TUBE. WOUND INFECTIONS (N=54) WAS REPORTED. GASTROJEJUNAL LEAKS (N=4) WERE ALSO REPORTED. TWO WERE DRAINED PERCUTANEOUSLY BY COMPUTED TOMOGRAPHY GUIDANCE. NO WOUND INFECTIONS WERE OBSERVED IN THESE TWO PATIENTS. THE OTHER TWO LEAKS ALSO SHOWED SEROSANGUINOUS DRAINAGE FROM THE WOUND AND WERE TREATED BY OPEN SURGICAL DRAINAGE. WHATEVER THE ACTUAL RATE OF WOUND INFECTION AND SUBSEQUENT HERNIA, THE COMPLICATION CAUSES SIGNIFICANT MORBIDITY AND SHOULD BE AVOIDED AT ALL COSTS. AS OF FEBRUARY 2002, THE AUTHORS HAVE ADOPTED A MINIMALLY INVASIVE APPROACH TO BARIATRIC SURGERY AND PERFORM LAPAROSCOPIC ISOLATED RYGBP (HAND-SEWN GASTROJEJUNOSTOMY) ALMOST EXCLUSIVELY, IN ORDER TO AVOID WOUND INFECTIONS AND SUBSEQUENT INCISIONAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293873 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention