BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7622657 · Received June 20, 2018

    Report

    Report Number
    2210968-2018-73604
    Event Type
    Injury
    Date Received
    June 20, 2018
    Report Date
    May 30, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: ENDOSCOPY. 2015; 47: E534 E535. DOI: HTTP://DX.DOI.ORG/10.1055/S-0034-1393040. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: CALCIUM OXALATE STONES IN A COLONIC SURGICAL SUTURE: AN UNCOMMON ENDOSCOPIC FINDING". AUTHORS: JOANA RIBEIRO DA SILVA, ROLANDO PINHO, IOLANDA RIBEIRO, ANA PONTE, JAIME RODRIGUES, AGOSTINHO LIRA, JOÃO CARVALHO. CITATION: ENDOSCOPY. 2015; 47: E534 E535. DOI: HTTP://DX.DOI.ORG/10.1055/S-0034-1393040. A 59-YEAR OLD BRAZILIAN WOMAN HAD UNDERGONE ILEOCOLONIC RESECTION IN 2004 WHILE IN BRAZIL. SHE WAS PRESENTED TO THE HOSPITAL WITH ABDOMINAL PAIN AND THE PASSAGE OF LIQUID STOOLS. COLONOSCOPY SHOWED AT THE ILEOCOLONIC ANASTOMOSIS A SURGICAL PROLENE SUTURE THAT THREADED THROUGH SEVERAL HARD SPHERICAL STRUCTURES, SIMILAR IN APPEARANCE TO ROSARY BEADS WHICH WAS CONFIRMED TO BE CALCIUM OXALATE STONES. THE SUTURE WAS CUT WITH ENDOSCOPIC SCISSORS AT BOTH ENTRY POINTS IN THE COLONIC WALL AND THE FOREIGN BODY WAS REMOVED WITH A GRASPING FORCEPS. IT WAS REPORTED THAT CALCIUM OXALATE CRYSTALS IN THE STOOL POSSIBLY ADHERED TO THE SURGICAL SUTURE, CREATING A NIDUS FOR SUBSEQUENT STONE GROWTH. THIS IS THE FIRST CASE REPORT OF A FOREIGN BODY REACTION TO A PROLENE SUTURE, WITH THE FORMATION OF MULTIPLE CALCIUM OXALATE STONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463253 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention