BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERI-STRIPS DRY

    MDR report key: 332658 · Received May 10, 2001

    Report

    Report Number
    2183620-2001-00007
    Event Type
    Other
    Date Received
    May 10, 2001
    Date of Event
    April 17, 2001
    Report Date
    April 17, 2001
    Manufacturer
    BIO-VASCULAR
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2001 PT UNDERWENT GASTRIC BYPASS WITH PERI-STRIPS DRY. ON EVENT DATE THE PT RETURNED FOR ROUTINE FOLLOW-UP AND FOR REASONS UNKNOWN TO BIO-VASCULAR, PT UNDERWENT AN ENDOSCOPY, WHICH REVEALED ULCERS (A COMMON POST-OPERATIVE COMPLICATION FOR THIS PROCEDURE AS REPORTED BY THE SURGEON). AT THAT TIME, PIECES OF PERI-STRIPS DRY WERE SEEN IN THE INNER LUMEN OF THE STOMACH AND JEJUNUM AND WERE REMOVED. ENDOSCOPY REVEALED NO LEAKAGE OF THE POUCH, AND THE SURGEON STATED HE BELIEVED THE PRODUCT MIGRATION HAPPENED SUBSEQUENT TO THE HEALING OF THE ORIGINAL WOULD CLOSURE. THE PT HAD NO REPORTED SYMPTOMS AND REQUIRED NO INTERVENTION OTHER THAN REMOVAL TO TREAT THE PRODUCT MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21801 PERI-STRIPS DRY STAPLE LINE REINFORCEMENT FTL BIO-VASCULAR PSD 5506-EN 532474

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention ETHICON ATW 45 STAPLER (2001 TO 2001).