BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX

    MDR report key: 6941789 · Received October 11, 2017

    Report

    Report Number
    3007321028-2017-00003
    Event Type
    Injury
    Date Received
    October 11, 2017
    Date of Event
    November 16, 2016
    Report Date
    October 11, 2017
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    PMA / PMN Number
    K130547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL/CMO REVIEW: NAUSEA AND DYSPHAGIA ARE COMMON COMPLICATIONS OF HIATAL HERNIA REPAIR. THE MOST COMMON CAUSE IS PLACEMENT OF THE MESH IN SUCH A FASHION THAT NOT ENOUGH SPACE IS LEFT FOR THE ESOPHAGUS IN DISTENDED FORM, I.E. DURING THE PASSAGE OF A BOLUS OF FOOD. THIS APPEARS TO BE THE CAUSE IN THIS CASE AS DILATION RESOLVED THE SYMPTOMS. THIS IS A TECHNIQUE ISSUE AND NOT AN IMPLANT SPECIFIC COMPLICATION.

    Description of Event or Problem · 1

    A LAPAROSCOPIC HIATAL HERNIA REPAIR WAS PERFORMED ON (B)(6) 2016. SMALL SPACE FOR MESH TO FIT AND MESH WAS CUT TO FIT SPACE. A KEYHOLE WAS CUT OUT OF THE MESH WITH THE 'LABELED SIDE DOWN' AND SUTURED IN WITHOUT FULLY ENCIRCLING THE ESOPHAGUS. POST OPERATIVELY, THE PATIENT EXPERIENCED NAUSEA AND VOMITING ON (B)(6) 2016. OVER THE NEXT FOUR WEEKS, THE PATIENT CONTINUED TO EXPERIENCE DYSPHAGIA WITH DIFFICULTY SWALLOWING. THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY TO DILATE THE ESOPHAGUS ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT REPORTED ALL SYMPTOMS HAD RESOLVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720464 OVITEX SURGICAL MESH FTM AROA BIOSURGERY LTD. OVITEX 1S ERT-6B15

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention