BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPRO LL

    MDR report key: 11706007 · Received April 22, 2021

    Report

    Report Number
    9612501-2021-00649
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    September 1, 2020
    Report Date
    April 22, 2021
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAW
    UDI-DI
    10884521038004
    PMA / PMN Number
    K050947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: CLINICAL TRIAL OF PANCREATICOGASTROSTOMY VERSUS PANCREATICOJEJUNOSTOMY REGARDING INCIDENCE OF DELAYED GASTRIC EMPTYING AFTER PANCREATICODUODENECTOMY SOURCE: LANGENBECK'S ARCHIVES OF SURGERY (2020) 405:921¿928. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE, A PROSPECTIVE STUDY COMPARED PANCREATICOGASTROSTOMY (PG) AND PANCREATICOJEJUNOSTOMY (PJ) WITH REGARD TO THE INCIDENCE OF DELAYED GASTRIC EMPTYING IN PATIENTS WHO UNDERWENT PANCREATICODUODENECTOMY BETWEEN MAY 2013 AND JANUARY 2016. THERE WERE 27 PG PATIENTS AND 26 PJ PATIENTS. THE DEVICE WAS USED FOR THE PANCREATICOGASTROSTOMY. COMPLICATIONS INCLUDED: BLOOD LOSS GREATER THAN 500ML, ABDOMINAL ABSCESS, AND INTRA-ABDOMINAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606927 SURGIPRO LL SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW DAVIS & GECK CARIBE LTD VP-585-X 10884521038004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention