BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERI-STRIPS DRY

    MDR report key: 336041 · Received June 1, 2001

    Report

    Report Number
    2183620-2001-00011
    Event Type
    Other
    Date Received
    June 1, 2001
    Date of Event
    March 23, 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 IN 05/2001 THAT IN 03/2001 PATIENT UNDERWENT GASTRIC BYPASS. 10 DAYS LATER A POSTOPERATIVE DISTAL POUCH LEAK AT LESSER CURVATURE WAS FOUND. CURRENT PATIENT STATUS IS STABLE. LEAK CLOSED. INTERVENTION: CT GUIDED DRAINAGE OF ABSCESS PERFORMED IN 03/2001. CONCOMITANT SURGERY: CHOLECYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25224 PERI-STRIPS DRY STAPLE LINE REINFORCEMENT FTL BIO-VASCULAR UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention