BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 7309722 · Received March 2, 2018

    Report

    Report Number
    1213643-2018-00440
    Event Type
    Injury
    Date Received
    March 2, 2018
    Date of Event
    September 14, 2015
    Report Date
    November 5, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016615
    PMA / PMN Number
    K922916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT A REMOVAL SURGERY "DUE TO MIGRATION OF THE BARD/DAVOL PERFIX PLUG THAT CAUSED THE PATIENT EXCRUCIATING PAIN." MEDICAL RECORDS WERE NOT PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED AT THIS TIME, NO CONCLUSIONS CAN BE MADE. ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT MANUFACTURING DATE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 4 MONTHS POST IMPLANT OF PERFIX PLUG, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, SEROMA AND PAIN THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS HERNIA RECURRENCE AND SEROMA AS POSSIBLE COMPLICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. 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.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A RECURRENT LEFT INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, LOT NUMBER HUWB1973, REFERENCE NUMBER (B)(4) WAS IMPLANTED. (B)(6) 2015: THE PATIENT UNDERWENT A REMOVAL SURGERY DUE TO MIGRATION OF THE BARD/DAVOL PERFIX PLUG THAT CAUSED THE PATIENT EXCRUCIATING PAIN. AS ALLEGED, THE PATIENT EXPERIENCED SIGNIFICANT LEFT GROIN PAIN DUE TO THE DEFECTIVE BARD/DAVOL PERFIX PLUG AND WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH LEFT SIDE DIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG AND PATCH. PER OPERATIVE NOTES, ¿ HERNIA SAC WAS COMPLETELY SEPARATED AND REDUCED BACK INTO PREPERITONEAL SPACE. A PERFIX PLUG WAS ATTACHED TO THE RIM OF THE DEFECT WITH INTERRUPTED SUTURES. THEN, A PERFIX PATCH WAS PLACED OVER THE AREA AND ATTACHED TO THE FASCIA WITH INTERRUPTED SUTURES.¿ (B)(6) 2015 - PATIENT DIAGNOSED WITH LEFT INGUINAL HERNIA. (B)(6) 2015 - DURING FOLLOW-UP VISIT, PATIENT WAS DIAGNOSED WITH SEROMA. (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA RECURRENCE, PROBABLE PLUG MIGRATION, PAIN ON LEFT GROIN THEREBY SCHEDULED OPEN AND ROBOTIC REPAIR WITH THE REMOVAL OF PERFIX PLUG. (NOTE: NO OP NOTES WERE PROVIDED). ATTORNEY ALLEGES THAT THE PATIENT HAD MESH MIGRATION, PAIN, HERNIA RECURRENCE, SEROMA, MESH REMOVAL AND EMOTIONAL INJURIES.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT A REMOVAL SURGERY "DUE TO MIGRATION OF THE BARD/DAVOL PERFIX PLUG THAT CAUSED THE PATIENT EXCRUCIATING PAIN." MEDICAL RECORDS WERE NOT PROVIDED. 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. 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. NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A RECURRENT LEFT INGUINAL HERNIA. A BARD/DAVOL PERFIX PLUG, LOT NUMBER HUWB1973, REFERENCE NUMBER 0112770 WAS IMPLANTED. ON (B)(6) 2015: THE PATIENT UNDERWENT A REMOVAL SURGERY DUE TO MIGRATION OF THE BARD/DAVOL PERFIX PLUG THAT CAUSED THE PATIENT EXCRUCIATING PAIN. AS ALLEGED, THE PATIENT EXPERIENCED SIGNIFICANT LEFT GROIN PAIN DUE TO THE DEFECTIVE BARD/DAVOL PERFIX PLUG AND WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152876 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUWB1973 00801741016615

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Disability| R