BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX ST MESH

    MDR report key: 12070083 · Received June 25, 2021

    Report

    Report Number
    1213643-2021-20164
    Event Type
    Injury
    Date Received
    June 25, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 17, 2021
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    OWT
    PMA / PMN Number
    K143380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, A PHASIX ST MESH WAS USED AS A FASCIAL BRIDGE AND SEVERAL MONTHS POST-IMPLANT, THE PATIENT EXPERIENCED WOUND DEHISCENCE AND IMPAIRED HEALING. THE SURGEON INDICATED, THE MESH MAY HAVE BEEN CONTRIBUTORY TO THE PATIENT OUTCOMES, THOUGH THE SURGEON DID NOT INDICATE AS POTENTIAL DEVICE ISSUE. THE SURGEON ALSO NOTED THE MESH WAS USED IN AN "OFF-LABEL" FASHION AND THE OUTCOMES SHOULD HAVE BEEN ANTICIPATED. THE DIRECTIONS FOR USE SECTION IN THE INSTRUCTIONS FOR USE STATES "THE SAFETY AND EFFECTIVENESS OF PHASIX¿ ST MESH IN BRIDGING REPAIRS HAS NOT BEEN EVALUATED OR ESTABLISHED. EVERY EFFORT SHOULD BE MADE TO CLOSE THE MIDLINE DEFECT PRIOR TO MESH USE." NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSIONS CAN BE MADE. NOTE, THE DATE OF EVENT IS CONSIDERED TO BE A BEST ESTIMATE AS (B)(6) 2021 BASED ON THE DATE OF AWARENESS. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED, THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR WITH A BARD/DAVOL PHASIX ST MESH AS A FASCIAL BRIDGE WITH SUBCUTANEOUS FAT AND SKIN CLOSED OVER TOP. AFTER SEVERAL MONTHS POST-IMPLANT, THERE WAS BREAKDOWN OF THE SKIN CLOSURE AND NOW HAS EXPOSED MESH WITH MINIMAL GRANULATION TISSUE. AS REPORTED PER THE SURGEON, "I THINK THAT THE PHASIX (ST) WAS POTENTIALLY THE CAUSE, BUT I THINK IT WAS ALSO BEING USED OFF-LABEL, SO I THINK WE MAYBE SHOULD HAVE BEEN ABLE TO ANTICIPATE IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967451 PHASIX ST MESH SURGICAL MESH OWT DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention