BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 3021640 · Received March 15, 2013

    Report

    Report Number
    1213643-2013-00101
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    March 19, 2012
    Report Date
    November 27, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016622
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO AVAILABLE AT THIS TIME, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THE PT REPORTED TO DAVOL THAT FOLLOWING IMPLANT SHE EXPERIENCED INCREASED PAIN. MEDICAL RECORDS SHOW THAT EIGHT MONTHS FOLLOWING IMPLANT SHE UNDERWENT MESH EXCISION. THE EXPLANTING SURGEON NOTED THAT HE EXPLANTED WHAT APPEARED TO BE A MESH BALL THAT DID NOT APPEAR TO HAVE BEEN TETHERED. THE EXCISED MESH WAS NOT RETURNED TO DAVOL; THEREFORE AN EVALUATION OF THIS REPORTED CONDITION COULD NOT BE CONDUCTED. A REVIEW OF THE MFG RECORDS WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. THE MEDICAL RECORDS INDICATE THAT THE PT WAS TREATED FOR ADHESIONS, WHICH IS A KNOWN POSSIBLE ADVERSE REACTION LISTED IN THE IFU. AT THIS TIME IT CANNOT BE DETERMINED TO WHAT DEGREE THE MESH MAY HAVE CAUSED OR CONTRIBUTED TO THE PROBLEMS REPORTED BY THE PT. BASED ON THE INFO PROVIDED IT IS POSSIBLE THAT THE MESH WAS NOT FULLY SECURED WHEN PLACED. IF ADD'L EVENT AND/OR EVALUATION INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON A REVIEW OF THE MEDICAL RECORDS PROVIDED BY THE PT: ON (B)(6) 2011 PT UNDERWENT REPAIR OF RIGHT INGUINAL HERNIA WITH PLACEMENT OF A BARD PERFIX PLUG. ON (B)(6) 2012 PT PRESENTED WITH EXQUISITE POINT TENDERNESS AND UNDERWENT EXCISION OF THE BARD PERFIX PLUG. DURING EXPLANT THE SURGEON NOTED "A SOLID MASS OF WHAT APPEARED TO BE A MESH BALL WAS RESECTED. IT DID NOT APPEAR TO BE TETHERED TO ANY OF THE SURROUNDING FASCIA." NO OTHER PATHOLOGIC ABNORMALITIES WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110824 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUVC1127 00801741016622

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Disability| R