BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7397231 · Received April 4, 2018

    Report

    Report Number
    2210968-2018-71889
    Event Type
    Injury
    Date Received
    April 4, 2018
    Report Date
    March 16, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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: AM J SURG. 1996; 172: 328 331 - [(B)(4)-BROLIN 1996.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: PROSPECTIVE, RANDOMIZED EVALUATION OF MIDLINE FASCIAL CLOSURE IN GASTRIC BARIATRIC OPERATION¿ AUTHORS: ROBERT E. BROLIN, MD CITATION: AM J SURG. 1996; 172: 328 331 . SEVERE OBESITY IS CITED AS A MAJOR RISK FACTOR FOR FASCIAL WOUND DEHISCENCE AND LATE INCISIONAL HERNIA AFTER MAJOR ABDOMINAL SURGERY. THE PURPOSE OF THIS STUDY WAS TO PROSPECTIVELY COMPARE TWO METHODS OF CLOSURE OF THE LINEA ALBA AFTER GASTRIC RESTRICTIVE OPERATIONS PERFORMED FOR TREATMENT OF MORBID OBESITY. A TOTAL OF 229 PATIENTS WERE INCLUDED IN THE STUDY. OF WHICH, 109 PATIENTS (20 MALE AND 89 FEMALE) HAD SURGICAL CLOSURE WITH ETHIBOND SUTURE AND 120 PATIENTS (24 MALE AND 96 FEMALE) HAD CLOSURE WITH PDS SUTURE. DURING THE SURGICAL PROCEDURE, THE CLOSURE OF THE LINEA ALBA WAS PERFORMED USING EITHER PDS 1-0 SUTURE OR ETHIBOND 1-0 SUTURE USING AN INTERRUPTED FIGURE-EIGHT TECHNIQUE. IN THE ETHIBOND SUTURES GROUP, REPORTED COMPLICATIONS INCLUDED ACUTE MIDLINE FASCIAL DEHISCENCE (N-2) WHICH REQUIRED REPAIR USING PDS 1-0 SUTURE PLACED IN A CONTINUOUS FASHION, LATE INCISIONAL HERNIA (N-20), AND SUTURE GRANULOMA (N-5) WHICH REQUIRED EXTRACTION OF MULTIPLE SUTURES. IN THE PDS SUTURES GROUP, REPORTED COMPLICATION INCLUDED LATE INCISIONAL HERNIA (N-11). IT WAS REPORTED THAT TECHNICAL AND MECHANICAL FACTORS THAT HAVE BEEN SHOWN TO INFLUENCE THE INCIDENCE OF FASCIAL DEHISCENCE INCLUDE THE TECHNIQUE OF CLOSURE, PROPERTIES OF THE SUTURE MATERIALS USED FOR CLOSURE, AND LOCATION OF THE INCISION. THE DOUBLE STRANDED SUTURE (PDS 1-0) USED IN THIS STUDY PROVIDES NEARLY TWICE THE INITIAL TENSILE STRENGTH OF A SINGLE STRAND OF THE SAME DIAMETER SYNTHETIC NON-ABSORBABLE SUTURE (ETHIBOND 1-0). THE INCREASED TENSILE STRENGTH PROVIDED BY THE DOUBLE STRAND SUTURE MAY BE PARTICULARLY IMPORTANT IN SEVERELY OBESE PATIENTS IN WHOM THE MECHANICAL FORCES WORKING AGAINST EARLY WOUND HEALING ARE MOST PROMINENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239421 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention