BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 8137301 · Received December 6, 2018

    Report

    Report Number
    1213643-2018-04426
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    July 24, 2014
    Report Date
    May 4, 2026
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741016622
    PMA / PMN Number
    K922916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE PATIENT'S POST-OP COMPLICATIONS CANNOT BE DETERMINED AT THIS TIME. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO SAMPLE WAS RETURNED FOR EVALUATION. NO MEDICAL RECORDS HAVE BEEN PROVIDED. RECURRENCE IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE INSTRUCTIONS-FOR-USE A POSSIBLE COMPLICATION. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: NO SAMPLE RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2009: THE PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR. A BARD/DAVOL EXTRA-LARGE PERFIX PLUG, REFERENCE NUMBER: 0112780, LOT NUMBER: HUSL0457 WAS IMPLANTED IN PATIENT DURING THIS REPAIR. ON (B)(6) 2014: THE PATIENT UNDERWENT ANOTHER PROCEDURE TO REMOVE THE PERFIX PLUG AND REPAIR THE RECURRENT LEFT INGUINAL HERNIA. THE PHYSICIAN NOTED THE PRESENCE OF A LARGE AMOUNT OF SCAR TISSUE AND, DESPITE THE PLUG BEING "EXTRA LARGE" HE DESCRIBED THE PLUG AS "SMALL OR MEDIUM-SIZED" BEFORE HE REMOVED IT. AS REPORTED, PATIENT CONTINUES TO SUFFER EXTREME TESTICULAR PAIN. AS ALLEGED, THE PERFIX PLUG IMPLANTED IN PATIENT FAILED TO REASONABLY PERFORM AS INTENDED. AS ALLEGED, PATIENT HAS BEEN INJURED SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, IMPAIRMENT DUE TO THE ALLEGED DEFECTIVE PERFIX PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486888 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUSL0457 00801741016622

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Disability| R