BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 9888535 · Received March 27, 2020

    Report

    Report Number
    1416980-2020-01775
    Event Type
    Injury
    Date Received
    March 27, 2020
    Report Date
    April 23, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE WAS NOT RETURNED, AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: FEBRUARY 2002 TO DECEMBER 2003. THE REPORTED PRODUCT IS AN UNKNOWN BAXTER PERI-STRIP. LITERATURE ARTICLE: S. YU, K. JASTROW, B. CLAPP, L. KAO, C. KLEIN, T. SCARBOROUGH, E. WILSON. ¿FOREIGN MATERIAL EROSION AFTER LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS: FINDINGS AND TREATMENT¿. SURG ENDOSC (2007) 21: 1216¿1220; DOI: 10.1007/S00464-007-9328-3. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED 153 PATIENTS UNDERWENT A TWO-YEAR STUDY IN WHICH PERI-STRIPS WERE USED WITH LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS. SIX PATIENTS EXPERIENCED POST-OPERATIVE EVENTS WITH INCIDENCE OF FOREIGN MATERIAL EROSION INTO THE GASTRIC POUCH. ONE PATIENT EXPERIENCED A GASTRO-JEJUNAL ANASTOMOTIC LEAK AND WAS ¿TREATED CONSERVATIVELY¿. THREE PATIENTS EXPERIENCED STRICTURES, FOUR PATIENTS EXPERIENCED MARGINAL ULCERATIONS, 13 PATIENTS EXPERIENCED NAUSEA, 12 PATIENTS EXPERIENCED VOMITING, THREE PATIENTS EXPERIENCED MELENA, FIVE PATIENTS EXPERIENCED DYSPHAGIA AND 15 PATIENTS EXPERIENCED ABDOMINAL PAIN. TREATMENT FOR THE EVENTS WAS NOT REPORTED. THE STUDY REPORTED THE ¿PATIENT OUTCOMES WERE DETERMINED BY RESOLUTION OF SYMPTOMS, IMPROVEMENT OF SYMPTOMS, OR NO EFFECT OR WORSENING OF SYMPTOMS AT FOLLOW-UP¿ (NO FURTHER DETAILS). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351039 NI MESH, SURGICAL FTM BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NON-BAXTER SILK SUTURE