BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT

    MDR report key: 5097928 · Received September 23, 2015

    Report

    Report Number
    1835959-2015-00213
    Event Type
    Injury
    Date Received
    September 23, 2015
    Date of Event
    August 25, 2015
    Report Date
    December 29, 2015
    Manufacturer
    COOK BIOTECH
    Product Code
    FTL
    PMA / PMN Number
    K111695
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME - HYBRID GRAFT. PRODUCT CODE - FTL. THE: 510K - K111695. ONGOING EFFORTS TO OBTAIN INFORMATION ARE OCCURRING. AT THIS TIME, IT APPEARS AS IF THE PATIENT PRESENTED WITH PAIN AND ABDOMINAL DISTENSION. THE SURGEON PERFORMED EXPLORATORY SURGERY AND FOUND DENSE ADHESIONS TO THE GRAFT AND EXPLANTED THE DEVICE. PATIENT IS RECOVERING AND HAS BEEN DISCHARGED FROM THE HOSPITAL AFTER HAVING A DIFFERENT DEVICE IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE ADHESIONS IS INCONCLUSIVE. HOWEVER, MANY FACTORS CAN INFLUENCE AND CONTRIBUTE TO ADHESION FORMATION INCLUDING, BUT NOT LIMITED TO A PATIENT'S TENDENCY TO FORM ADHESIONS, AN ABDOMINAL PROCEDURE, ANY DAMAGE TO THE BOWEL DURING THE INITIAL SURGERY, EXCESSIVE TISSUE INCISIONS, HISTORY OF PRIOR SURGERIES, EXCESSIVE HANDLING OF VISCERA, POST-OPERATIVE ACTIVITIES, AND NUTRITION. ADHESION FORMATION IS LISTED AS A POTENTIAL COMPLICATION IN THE IFU.

    Description of Event or Problem · 1

    COMPLICATIONS AFTER PROCEDURE. PATIENT PRESENTED WITH PAIN AND ABDOMINAL DISTENSION. SURGEON FOUND ADHESIONS AND SUBSEQUENTLY REMOVED THE DEVICE.

    Description of Event or Problem · 1

    COMPLICATIONS AFTER PROCEDURE. PATIENT PRESENTED WITH PAIN AND ABDOMINAL DISTENSION. SURGEON FOUND ADHESIONS AND SUBSEQUENTLY REMOVED THE DEVICE. UPDATE: THE SURGEON PLACED A C-HYB-15D IN A (B)(6) MALE PATIENT ON (B)(6) 2015 IN A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM) PROCEDURE. AT SOME POINT POST OP THE PATIENT BEGAN EXPERIENCING PAIN, ABDOMINAL DISTENSION, AND ELEVATED C-REACTIVE PROTEIN (CRP) LAB VALUES. ON (B)(6) 2015, THE PATIENT UNDERWENT A LAPAROSCOPIC RE-LOOK AND THE ZENAPRO WAS FOUND ADHERED TO THE SMALL BOWEL. THE SURGEON EXPLANTED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627529 ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT HYBRID GRAFT FTL COOK BIOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR