BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7449848 · Received April 22, 2018

    Report

    Report Number
    2210968-2018-72251
    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 1, A (B)(6) MULTIPAROUS WOMAN WITH NO PREVIOUS ABDOMINAL SURGERIES PRESENTED TO THE UROGYNECOLOGY CLINIC WITH SYMPTOMATIC PELVIC ORGAN PROLAPSE. DURING THE SURGERY, ONE STITCH OF 0-PROLENE (ETHICON, (B)(4)) AND 0-PDS (ETHICON, (B)(4)) SUTURE WERE PLACED IN THE MID-PORTION OF THE UTEROSACRAL LIGAMENTS BILATERALLY. THE PDS SUTURES WERE THEN PASSED THROUGH THE ANTERIOR AND POSTERIOR VAGINAL CUFF EPITHELIUM BILATERALLY AND THE PROLENE SUTURES WERE PASSED THROUGH THE MUSCULARIS OF THE ANTERIOR AND POSTERIOR VAGINAL WALL BILATERALLY. ON POSTOPERATIVE DAY 1, THE PATIENT DEVELOPED NAUSEA, VOMITING, AND ABDOMINAL DISTENTION, WHICH WORSENED THE FOLLOWING DAY. ON POSTOPERATIVE DAY 2, A PLAIN ABDOMINAL RADIOGRAPHIC FILM REVEALED MULTIPLE DILATED LOOPS OF SMALL BOWEL CONSISTENT WITH EARLY OR PARTIAL SMALL BOWEL OBSTRUCTION. CONSERVATIVE MANAGEMENT INCLUDING BOWEL REST, FLUID RESUSCITATION, AND BOWEL DECOMPRESSION VIA A NASOGASTRIC TUBE WAS BEGUN. HOWEVER, AFTER 8 DAYS OF CONSERVATIVE MANAGEMENT WITHOUT SIGNIFICANT SUSTAINED IMPROVEMENT, SURGICAL INTERVENTION WAS RECOMMENDED. ON DAY 14, THE PATIENT WAS ABLE TO TOLERATE A REGULAR DIET AND WAS DISCHARGED HOME. 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
    292520 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention