BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7449854 · Received April 22, 2018

    Report

    Report Number
    2210968-2018-72255
    Event Type
    Injury
    Date Received
    April 22, 2018
    Report Date
    March 27, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: INT UROGYNECOL J (2007) 18:1237¿1241; DOI 10.1007/S00192-007-0346-4; PUBLISHED ONLINE: 27 MARCH 2007 - (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: SMALL BOWEL OBSTRUCTION AFTER VAGINAL VAULT SUSPENSION: A SERIES OF THREE CASES¿ AUTHORS: BERI RIDGEWAY, MATTHEW D. BARBER, MARK D. WALTERS AND MARIE FIDELA R. PARAISO CITATION: INT UROGYNECOL J (2007) 18:1237¿1241; DOI 10.1007/S00192-007-0346-4; PUBLISHED ONLINE: 27 MARCH 2007 THIS CASE STUDY PRESENTED A THOROUGH REVIEW OF THE LITERATURE THAT REVEALED NO PREVIOUS REPORTS OF PRIMARY VAGINAL RECONSTRUCTIVE SURGERY LEADING TO SMALL BOWEL OBSTRUCTION (SBO) IN FEMALE PATIENTS. IN CASE 3, A (B)(6) MULTIPAROUS WOMAN WITH A HISTORY OF AN ABDOMINAL HERNIA REPAIR PRESENTED TO THE UROGYNECOLOGY CLINIC WITH THE COMPLAINT OF UTERINE PROLAPSE AND OCCASIONAL STRESS URINARY INCONTINENCE. DURING THE SURGERY, A SINGLE STITCH OF 0-PDS WAS PLACED IN THE UTEROSACRAL LIGAMENTS AND A STITCH USING 0-PROLENE WAS THEN PLACED CAUDALLY THROUGH ONE UTEROSACRAL LIGAMENT AND USED TO TRAVEL ACROSS THE PERITONEUM. ON POSTOPERATIVE DAY 17, THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND UNDERWENT DIAGNOSTIC LAPAROSCOPY, EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION, AND END-TO-END ENTEROENTEROSTOMY. DURING THE LAPAROSCOPIC PORTION OF THE PROCEDURE, ADHESIONS WERE NOTED BETWEEN THE SMALL BOWEL AND THE OPERATIVE PEDICLES. THE PATIENT¿S POSTOPERATIVE COURSE WAS UNCOMPLICATED WITH THE EXCEPTION OF A MILD WOUND INFECTION, WHICH WAS TREATED WITH DRAINAGE AND ORAL ANTIBIOTICS. IN CONCLUSION, THE AUTHORS NOTED THAT A POSSIBLE NEW TREND OF PLACING VAGINAL VAULT SUSPENSION SUTURES MORE PROXIMAL IN THE UTEROSACRAL LIGAMENT PREDISPOSES TO SMALL BOWEL OBSTRUCTION. THE PATIENT¿S POSTOPERATIVE COURSE WAS UNCOMPLICATED WITH THE EXCEPTION OF A MILD WOUND INFECTION, WHICH WAS TREATED WITH DRAINAGE AND ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292524 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention