BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX MESH

    MDR report key: 19277755 · Received May 9, 2024

    Report

    Report Number
    1213643-2024-00246
    Event Type
    Injury
    Date Received
    May 9, 2024
    Date of Event
    April 10, 2024
    Report Date
    May 6, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    OOD
    UDI-DI
    00801741107580
    PMA / PMN Number
    K161424
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN POST IMPLANT OF PHASIX MESH WHICH HAS RESOLVED WITH THE MEDICATION PROVIDED. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE AS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. PAIN IS A CLINICALLY UNDERSTOOD POTENTIAL COMPLICATION OF SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS A POSSIBLE COMPLICATION. REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : NOT RETURNED

    Description of Event or Problem · 0

    EVENT REPORTED PER THE CLINICAL TRIAL DVL-HE-018: THE SUBJECT PATIENT UNDERWENT AN OPEN RELAPAROTOMY WITH COLECTOMY CONCOMITANT OSTOMY CREATION/REVISION/REVERSAL AND FISTULA TAKEDOWN PROCEDURE ON (B)(6) 2023, DURING WHICH A PHASIX MESH WAS TRIMMED, PLACED IN ONLAY FASHION, AND SECURED IN PLACE WITH ABSORBABLE MONOFILAMENT 3-0 VICRYL SUTURES. A 3 CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH SLOW ABSORBABLE MONOFILAMENT 1-0 PDS SUTURES. THE PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2023. ON (B)(6) 2024, THE SUBJECT PATIENT EXPERIENCED ABDOMINAL PAIN. IT WAS REPORTED THAT THE PATIENT UNDERWENT CT SCAN AND MEDICATION (IV HYDRATION, ANTIEMETIC, ANALGESIC) WAS PROVIDED. NO ACTION WAS TAKEN TO THE STUDY DEVICE. THE PATIENT WAS DISCHARGED WITH BENTYL AND ZOFRAN. AS REPORTED, THE REPORTED ADVERSE EVENT (ABDOMINAL PAIN) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE AE HAS BEEN ASSESSED AS MILD IN SEVERITY. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548473 PHASIX MESH SURGICAL MESH OOD DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUGT1606 00801741107580

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention