BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX MESH

    MDR report key: 17924755 · Received October 12, 2023

    Report

    Report Number
    1213643-2023-00367
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    January 1, 2014
    Report Date
    September 29, 2023
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    OOD
    PMA / PMN Number
    K142818
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CONTENTS OF THE ARTICLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION PROVIDED IS LIMITED TO THE ARTICLE. THE JOURNAL ARTICLE DID NOT INCLUDE ANY ANALYSIS OF HOW OR IF THE PHASIX FLAT MESH POTENTIALLY CAUSED OR CONTRIBUTED TO ANY PATIENT OUTCOME OR COMPLICATIONS. INFECTION, SEROMA, HEMATOMA, FISTULA AND HERNIA RECURRENCE ARE KNOWN INHERENT RISKS OF SURGERY AND ARE LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE AS POSSIBLE COMPLICATIONS. REGARDING INFECTION THE WARNING SECTION STATES, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE MESH. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE DEVICE". NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT IS CONSIDERED TO BE A BEST ESTIMATE AS (B)(6) 2014 BASED ON THE INFORMATION AVAILABLE. 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

    PER JOURNAL ARTICLE ¿POLY-4-HYDROXYBUTYRATE MESH FOR VENTRAL HERNIA REPAIRS: A SINGLE-SURGEON EXPERIENCE¿. THE ARTICLE IS A RETROSPECTIVE STUDY OF 169 ADULTS WHO UNDERWENT OPEN VENTRAL HERNIA REPAIR (VHR) WITH POLY-4-HYDROXYBUTYRATE (P4HB) (PHASIX) MESH BY A SINGLE SURGEON PERFORMED BETWEEN 2014 TO 2020. 81 OF THE PATIENTS WERE REPORTED TO HAVE HAD A PRIOR VHR AND 31 PATIENTS WERE NOTED TO HAVE HAD A PRIOR MESH INFECTION. 37 OF THE 169 STUDY PATIENTS HAD POSTOPERATIVE SURGICAL SITE OCCURRENCES WHICH INCLUDED CELLULITIS (11), SURGICAL SITE INFECTION (16), SEROMA (3), HEMATOMA (6), NONHEALING INCISIONAL WOUND (14), FASCIAL DEHISCENCE (10), INFECTED MESH (3), AND ENTEROCUTANEOUS FISTULA (3). IN ADDITION, THERE WERE 8 HERNIA RECURRENCE REPORTED DURING THE FOLLOW-UP PERIOD (12-18 MONTHS). OVERALL, 36 READMISSIONS WITH 30 REOPERATIONS WERE NOTED. THE ARTICLE DOES NOT REPORT ANY DEVICE SPECIFIC ISSUE. BASED ON THEIR RETROSPECTIVE REVIEW THE AUTHORS CONCLUDED ¿VENTRAL HERNIA REPAIR WITH P4HB BIOSYNTHETIC MESH PRODUCES ACCEPTABLE RATES OF RECURRENCE IN BOTH ONLAY AND RETRORECTUS PLANES WITH A FAVORABLE COMPLICATION PROFILE TO BIOLOGIC AND SYNTHETIC MESHES. PREDICTORS OF HERNIA RECURRENCE INCLUDE A HISTORY OF PRIOR HERNIA REPAIR, HYPERTENSION, AND IMMUNOSUPPRESSION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2116515 PHASIX MESH SURGICAL MESH OOD DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention