BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX MESH

    MDR report key: 21687827 · Received March 25, 2025

    Report

    Report Number
    1213643-2025-00223
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    February 16, 2025
    Report Date
    March 10, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    OOD
    UDI-DI
    00801741137327
    PMA / PMN Number
    K161424
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE PATIENT WAS DIAGNOSED WITH A SUBCUTANEOUS ABSCESS POST IMPLANT OF PHASIX MESH. THE CLINICIAN (MEDICAL MONITOR) HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE OF SUBCUTANEOUS ABSCESS AS PROBABLY RELATED TO THE STUDY DEVICE WITH A CAUSAL RELATIONSHIP TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE MADE. 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. 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.

    Description of Event or Problem · 0

    AS REPORTED PER PREVENT CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT UNDERWENT A COLECTOMY PRIMARY LAPAROTOMY LAPAROSCOPIC UMBILICAL PROCEDURE ON (B)(6) 2025, DURING WHICH PHASIX MESH ONLAY WAS TRIMMED AND IMPLANTED USING ABSORBABLE MONOFILAMENT SUTURE. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH SLOW ABSORBING MONOFILAMENT SUTURES. THE SUBJECT PATIENT DIAGNOSED WITH A SUBCUTANEOUS ABSCESS ON (B)(6) 2025. ACTION TAKEN IS LISTED AS "NURSING CARE." AS REPORTED, THE ADVERSE EVENT (SUBCUTANEOUS ABSCESS) HAS BEEN ASSESSED PER CLINICIAN (STUDY SITE INVESTIGATOR) AS CAUSAL RELATIONSHIP TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE AND NOT RECOVERED/RESOLVED. THE ADVERSE EVENT HAS BEEN ASSESSED PER CLINICIAN (MEDICAL MONITOR) AS PROBABLY RELATED TO THE STUDY DEVICE AND CAUSAL RELATIONSHIP TO THE PROCEDURE. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1696381 PHASIX MESH SURGICAL MESH OOD DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUHT0632 00801741137327

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention