BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7449852 · Received April 22, 2018

    Report

    Report Number
    2210968-2018-72253
    Event Type
    Injury
    Date Received
    April 22, 2018
    Report Date
    March 27, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    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) - RIDGEWAY 2007.PDF].

    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 2, A (B)(6)-YEAR-OLD MULTIPAROUS WOMAN WITH NO PREVIOUS ABDOMINAL SURGERIES PRESENTED TO THE UROGYNECOLOGY CLINIC WITH THE COMPLAINT OF SYMPTOMATIC PELVIC ORGAN PROLAPSE. DURING THE SURGERY, ONE FIGURE-OF-EIGHT STITCH OF 0-PROLENE AND TWO FIGURE-OF-EIGHT STITCHES OF 0-PDS WERE PLACED IN THE HIGH UTEROSACRAL LIGAMENTS BILATERALLY AND LATER ATTACHED TO THE VAGINAL CUFF MUSCULARIS AND EPITHELIUM, RESPECTIVELY. BOWEL OBSTRUCTION WAS NOTED AND LAPAROSCOPY WAS PERFORMED REVEALING AN AREA OF SMALL BOWEL CAUGHT IN A PROLENE SUTURE AT THE UTEROSACRAL LIGAMENT VAGINAL VAULT SUSPENSION SITE IN THE PELVIS AND A RELATED BOWEL WALL HEMATOMA. 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
    292523 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention