BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX ST MESH

    MDR report key: 14434650 · Received May 19, 2022

    Report

    Report Number
    1213643-2022-00233
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    December 13, 2017
    Report Date
    May 9, 2022
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    OWT
    UDI-DI
    00801741095337
    PMA / PMN Number
    K143380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE PATIENT DEVELOPED A HERNIA RECURRENCE POST-IMPLANT OF PHASIX ST MESH AND UNDERWENT ESOPHAGRAM TO CONFIRM THE HERNIA RECURRENCE. AS REPORTED, THE AE IS NOT RESOLVED. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE AS BEING ¿POSSIBLY¿ RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE, HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE MADE. HERNIA RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS HERNIA RECURRENCE AS A POSSIBLE COMPLICATION. NOT RETURNED - REMAINS IMPLANTED.

    Description of Event or Problem · 0

    REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2017 - THE SUBJECT PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF FIRST TIME RECURRENT PARAESOPHAGEAL HIATAL HERNIA ALONG WITH TOUPET FUNDOPLICATION AND ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURES. A PHASIX ST MESH WAS PLACED IN UNDERLAY FASHION INTRA-PERITONEALLY, FIXATED USING VICRYL SUTURES AT 4 FIXATION POINTS. FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES AND ADHESIVE SKIN CLOSURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2017. ON (B)(6) 2017 - THE PATIENT WAS DIAGNOSED WITH PARAESOPHAGEAL HIATAL HERNIA (PEH) RECURRENCE FOLLOWING AN ESOPHAGRAM SCAN. ON (B)(6) 2018 - DURING PHYSICAL EXAM PARAESOPHAGEAL HIATAL HERNIA (PEH) RECURRENCE WAS NOTED. THE AE IS CLINICALLY ASSESSED TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THIS HAS BEEN ASSESSED AS A NON-SERIOUS ADVERSE EVENT OF MILD SEVERITY, AND HAS NOT RESOLVED, THERE HAS BEEN NO ACTION TAKEN. THE REPORTED ADVERSE EVENT DOES NOT MEET THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2094459 PHASIX ST MESH SURGICAL MESH OWT DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUBN0723 00801741095337

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention