BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX MESH

    MDR report key: 16899116 · Received May 9, 2023

    Report

    Report Number
    1213643-2023-00185
    Event Type
    Injury
    Date Received
    May 9, 2023
    Date of Event
    June 2, 2021
    Report Date
    June 22, 2023
    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
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE MADE. THE REPORTED ADVERSE EVENT (ABDOMINAL PAIN, NAUSEA AND VOMITING) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF 28 UNITS RELEASED FOR DISTRIBUTION IN (B)(6) 2020. ADDENDUM: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED, TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. AS REPORTED, THE INITIALLY REPORTED PATIENT SYMPTOMS (NAUSEA, ABDOMINAL PAIN, VOMITING) WERE FOUND TO BE ASSOCIATED WITH THE PATIENT CONDITION MESENTERIC ISCHEMIA, WHICH HAS BEEN ASSESSED PER THE CLINICIAN AS NOT RELATED TO THE STUDY DEVICE. BASED ON THE ADDITIONAL INFORMATION PROVIDED NO PATIENT ADVERSE EVENT OCCURRED ASSOCIATED WITH THE PHASIX MESH USED TO TREAT THE PATIENT. UPDATED FIELDS: B4, B5, B7, G3, G6, H2, H6, H10. CORRECTED FIELD: E3 (INITIAL REPORTER OCCUPATION) 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 - REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE MADE. THE REPORTED ADVERSE EVENT (ABDOMINAL PAIN, NAUSEA AND VOMITING) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION IN APRIL 2020. 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 - REMAINS IMPLANTED.

    Description of Event or Problem · 0

    AS REPORTED PER THE CLINICAL TRIAL DVL-HE-018: THE SUBJECT PATIENT HAD AN OPEN MIDLINE UMBILICAL HERNIA REPAIR SURGERY ON (B)(6) 2011. THE SUBJECT PATIENT UNDERWENT AN OPEN PRIMARY LAPAROTOMY EPIGASTRIC AORTO-MESENTERIC BYPASS, DURING WHICH A BARD/DAVOL PHASIX MESH ONLAY (CAT NO #1191025 AND LOT NO # HUDZ2133) 4 X 10 RECTANGLE (10 X 25 CM) WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MULTIFILAMENT 3.0 VICRYL SUTURES. THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2021. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH AND THE MIDLINE FASCIA WAS COMPLETELY CLOSED. A 3CM OVERLAP IN ALL DIRECTIONS WAS ACHIEVED. PROPHYLACTIC ANTIBIOTIC CLINDAMYCIN WERE USED PERIOPERATIVELY. SKIN CLOSURE WAS ACHIEVED WITH LONG-TERM ABSORBABLE SUTURE AND SURGICAL GLUE. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021. ON (B)(6) 2021 - THE PATIENT DIAGNOSED WITH ABDOMINAL PAIN, NAUSEA AND VOMITING AND WAS TREATED WITH MEDICATION. AS REPORTED, DEVIATION FROM PROTOCOL DEFINED PROCEDURE, RATIO OF SUTURE: LENGTH FOR FASCIAL CLOSURE DID NOT FALL WITHIN EXPECTED RANGE. THE REPORTED ADVERSE EVENT (ABDOMINAL PAIN, NAUSEA AND VOMITING) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE AE HAS BEEN ASSESSED AS MILD IN SEVERITY. THE REPORTED AE DOES MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT). ADDENDUM PER ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH MESENTERIC ISCHEMIA ON (B)(6) 2021, MILD IN SEVERITY AND HAD REQUIRED OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THE ISCHEMIA WAS NOT RELATED TO THE STUDY DEVICE, POSSIBLY RELATED TO THE PROCEDURE, RECOVERED/RESOLVED AND DOES MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

    Description of Event or Problem · 0

    AS REPORTED PER THE CLINICAL TRIAL (B)(4): ON (B)(6)2021 THE SUBJECT PATIENT UNDERWENT AN OPEN PRIMARY LAPAROTOMY EPIGASTRIC AORTO-MESENTERIC BYPASS DURING WHICH A PHASIX MESH WAS TRIMMED AND PLACED IN ONLAY FASHION USING ABSORBABLE MULTIFILAMENT 3.0 VICRYL SUTURES. THE SUBJECT PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6)2021. ON (B)(6)2021, THE PATIENT EXPERIENCED ABDOMINAL PAIN, NAUSEA AND VOMITING AND WAS TREATED WITH MEDICATION. THE REPORTED ADVERSE EVENT (ABDOMINAL PAIN, NAUSEA AND VOMITING) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE AE HAS BEEN ASSESSED AS MILD IN SEVERITY. THE REPORTED AE DOES MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882741 PHASIX MESH SURGICAL MESH OOD DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUDZ2133 00801741107580

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Hospitalization| R