BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX ST MESH

    MDR report key: 7844135 · Received September 4, 2018

    Report

    Report Number
    1213643-2018-03000
    Event Type
    Injury
    Date Received
    September 4, 2018
    Date of Event
    April 26, 2018
    Report Date
    November 28, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    OWT
    UDI-DI
    00801741095351
    PMA / PMN Number
    K143380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS AN ADDENDUM TO THE INITIAL EMDR TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. BASED ON THE INFORMATION PROVIDED, IT APPEARS THAT THE INITIAL REPORT OF A SEROMA WAS ACTUALLY A HERNIA RECURRENCE THAT WAS LATER CONFIRMED VIA ULTRASOUND. RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THE LOT WAS MANUFACTURED TO SPECIFICATION. NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE HERNIA IDENTIFIED. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT, WHO IS PART OF PHASIX ST CLINICAL STUDY (B)(4) DEVELOPED A SEROMA. THE SUBJECT PATIENT UNDERWENT REPAIR OF AN UMBILICAL HERNIA WITH IMPLANT OF THE PHASIX ST MESH. THE MESH WAS SECURED USING MECHANICAL FIXATION AND ABSORBABLE MONOFILAMENT SUTURE. ON (B)(6) 2018 THE SUBJECT PATIENT WAS DIAGNOSED WITH A SEROMA. THE SEROMA HAS BEEN ASSESSED BY THE CLINICIAN AS A MILD, NON-SERIOUS EVENT THAT DID NOT REQUIRE ADDITIONAL MEDICAL OR SURGICAL TREATMENT, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. AS REPORTED, THE SEROMA HAS NOT RESOLVED AT THIS TIME. IT DOES NOT APPEAR AT THIS TIME THAT TREATMENT WAS PERFORMED TO ADDRESS THE SEROMA, HOWEVER AS THIS MAY REQUIRE MEDICAL/SURGICAL INTERVENTION, A SERIOUS INJURY MDR IS FILED TO DOCUMENT THE EVENT. ADDENDUM: IT WAS REPORTED THAT WHEN THE PATIENT WAS AT THE CLINIC ON (B)(6) 2018, THERE WAS AN AREA THAT WAS CONCERNING FOR SEROMA VS. RECURRENCE. AN ULTRASOUND WAS PERFORMED ON (B)(6) 2018 CONFIRMING FOR A SMALL FAT CONTAINING HERNIA AT THE INFRA UMBILICAL REGION. AN ADDITIONAL ULTRASOUND WAS PERFORMED ON (B)(6) 2018, THE FINDINGS WERE THE SAME, A SMALL FAT CONTAINING HERNIA IN THE UMBILICAL REGION. THE RECURRENCE HAS BEEN ASSESSED BY THE CLINICIAN AS A MILD NON-SERIOUS EVENT THAT HAS NOT REQUIRED ADDITIONAL MEDICAL OR SURGICAL TREATMENT, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE MADE. AS REPORTED THERE HAS BEEN NO MEDICAL INTERVENTION AT THIS TIME AND THE SEROMA HAS NOT RESOLVED. SEROMA IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. AS REPORTED THERE WAS NO MALFUNCTION OF THE DEVICE USED TO TREAT THE PATIENT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: THE INFORMATION PROVIDED BY BARD 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 BARD. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, WHO IS PART OF PHASIX ST CLINICAL STUDY (B)(4) DEVELOPED A SEROMA. THE SUBJECT PATIENT UNDERWENT REPAIR OF AN UMBILICAL HERNIA WITH IMPLANT OF THE PHASIX ST MESH. THE MESH WAS SECURED USING MECHANICAL FIXATION AND ABSORBABLE MONOFILAMENT SUTURE. ON (B)(6) 2018 THE SUBJECT PATIENT WAS DIAGNOSED WITH A SEROMA. THE SEROMA HAS BEEN ASSESSED BY THE CLINICIAN AS A MILD, NON-SERIOUS EVENT THAT DID NOT REQUIRE ADDITIONAL MEDICAL OR SURGICAL TREATMENT, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. AS REPORTED, THE SEROMA HAS NOT RESOLVED AT THIS TIME. IT DOES NOT APPEAR AT THIS TIME THAT TREATMENT WAS PERFORMED TO ADDRESS THE SEROMA, HOWEVER AS THIS MAY REQUIRE MEDICAL/SURGICAL INTERVENTION, A SERIOUS INJURY MDR IS FILED TO DOCUMENT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684174 PHASIX ST MESH SURGICAL MESH OWT DAVOL INC., SUB. C.R. BARD, INC. NA HUAU0516 00801741095351

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention