BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERI-STRIPS DRY

    MDR report key: 335677 · Received June 1, 2001

    Report

    Report Number
    2183620-2001-00010
    Event Type
    Other
    Date Received
    June 1, 2001
    Date of Event
    March 10, 2001
    Report Date
    May 10, 2001
    Manufacturer
    BIO-VASCULAR
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED THAT 5 DAYS PRIOR TO EVENT DATE PATIENT UNDERWENT A GASTRIC BYPASS SURGERY. ON EVENT DATE A LEAK IN THE GASTRIC CURVE OF THE GASTRIC POUCH SUTURE LINE WAS DIAGNOSED WITH BREAKDOWN OF PROXIMAL POUCH AND DISTAL REMNANT SUTURE LINES. SURGEON STATED THE PERI-STRIPS DRY HAD MIGRATED FROM THE GASTRIC POUCH AND WERE FREE-FLOATING IN THE ABDOMEN WITH STAPLES INTACT. CURRENT PATIENT STATUS IS STABLE POST ESOPHAGOGASTROECTOMY. INTERVENTIONS: ON EVENT DATE: LAPAROSCOPY, ABDOMINAL ABSCESS DRAINAGE, WIDE DRAINAGE OF LEAK. 9 DAYS AFTER EVENT DATE: TRACHEOSTOMY, VENA CAVA FILTER PLACEMENT. IN 04/2001: LAPAROTOMY, FLEXIBLE GASTROSCOPY, OVERSEWING GASTRIC POUCH (X2). IN 05/1: ESOPHAGOGASTROECTOMY, SMALL BOWEL RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25284 PERI-STRIPS DRY STAPLE LINE REINFORCEMENT FTL BIO-VASCULAR UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R