BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-STRIPS DRY W/VERITAS COLLAGEN MATRIX

    MDR report key: 1962859 · Received January 13, 2011

    Report

    Report Number
    2183620-2011-00005
    Event Type
    Injury
    Date Received
    January 13, 2011
    Report Date
    December 15, 2010
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K041669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. JOURNAL ARTICLE: GANDSAS, A: INITIAL OUTCOMES FOLLOWING LAPAROSCOPIC SLEEVE GASTRECTOMY IN 292 PTS AS A SINGLE-STAGE PROCEDURE FOR MORBID OBESITY. BARIATRIC TIMES. 2010; 7(2):11-13.

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX STAPLE LINE REINFORCEMENT (PSDV) WAS USED AS A STAPLE LINE BUTTRESS DURING LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) PROCEDURES. IN 292 PTS, LSG WAS PERFORMED AS A SINGLE-STAGE APPROACH FOR THE TREATMENT OF MORBID OBESITY AND ITS EFFECTIVENESS WAS EVALUATED DURING THE FIRST 12 MONTHS FOLLOWING SURGERY. ONE PT SUFFERED POST-OPERATIVE BLEEDING FROM THE STAPLE LINES FOLLOWING SURGERY WHICH REQUIRED UNSPECIFIED INTERVENTION. NO MAJOR INTRA-OPERATIVE BLEEDING FROM THE STAPLE LINES WAS NOTED AT THE TIME OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERI-STRIPS DRY W/VERITAS COLLAGEN MATRIX STAPLE LINE BUTTRESS FTM SYNOVIS SURGICAL INNOVATIONS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other