BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERI-STRIPS DRY

    MDR report key: 315564 · Received February 8, 2001

    Report

    Report Number
    2183620-2001-00005
    Event Type
    Other
    Date Received
    February 8, 2001
    Date of Event
    December 15, 2000
    Report Date
    January 25, 2001
    Manufacturer
    BIO-VASCULAR
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT BARIATRIC SURGERY IN 2000 FOR MORBID OBESITY. DEVELOPED SYMPTOMS OF GI BLEED ON THE EVENT DATE, INCLUDING FALLING HEMATOCRIT AND BLOODY STOOLS. PERI-STRIPS DRY WAS USED TO BUTRESS THE JEJUNAL-JENUNAL (J-J) ANASTOMOSIS BUT THE SURGEON DID NOT OVERSEW THE BUTRESS AS IS USUAL PROCEDURE WHEN NOT USING PERI-STRIPS DRY. NO SURGICAL INTERVENTION REPORTED. PT RECEIVED NON-BLOOD FLUID TO SUPPORT URINE OUTPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4737 PERI-STRIPS DRY STAPLE LINE REINFORCEMENT FTL BIO-VASCULAR UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention