BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 7274655 · Received February 15, 2018

    Report

    Report Number
    1213643-2018-00301
    Event Type
    Injury
    Date Received
    February 15, 2018
    Date of Event
    January 26, 2017
    Report Date
    September 19, 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. TO DATE NO MEDICAL RECORDS HAVE BEEN PROVIDED. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND "REMOVE IT." MEDICAL RECORDS WERE NOT PROVIDED AND THE DESCRIPTION DOES NOT CLEARLY DEFINE WHAT "REMOVE IT" IS REFERRING TO (EXAMPLE POSSIBLE MESH EXPLANT, PARTIAL EXPLANT, OR REMOVAL/REPAIR OF THE HERNIA DEFECT ITSELF WITHOUT EXPLANT OF PREVIOUSLY PLACED MESH). AS SUCH AT THIS TIME, WE HAVE NOT IDENTIFIED THIS AS REPORTED DEVICE EXPLANT. IT IS UNCLEAR AT THIS TIME IF THE HERNIA DEFECT REPAIRED POST IMPLANT OF THE MESH WAS A RECURRENCE OF THE ORIGINAL HERNIA DEFECT OR A NEW HERNIA DEFECT, HOWEVER, RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. ADDENDUM #1: THIS IS AN ADDENDUM TO THE INITIAL MDR TO CORRECT THE EXPIRATION DATE. ADDENDUM #2: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE 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 FEW MONTHS POST IMPLANT OF PERFIX PLUG, PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN, ERYTHEMA AND HEMATOMA THEREBY UNDERWENT REPAIR WITH REMOVAL SURGERY. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS HEMATOMA AS A POSSIBLE COMPLICATION. REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. UPDATED FIELDS. CORRECTED FIELD: H4 (MANUFACTURING DATE) 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. H3 OTHER TEXT : NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THIS IS AN ADDENDUM TO THE INITIAL MDR TO CORRECT THE EXPIRATION DATE. SHOULD ADDITIONAL INFORMATION BE PROVIDED AN ADDITIONAL SUPPLEMENTAL EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2005: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA. AS REPORTED, A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER 0112770, LOT NUMBER 43EPD128 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2017: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND "REMOVE IT." AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE PERFIX PLUG. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA WITH ENLARGED INGUINAL LYMPH NODE THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG. PER OPERATIVE NOTES, ¿A LARGE MASS OF LYMPH NODE WAS SEEN INFERIOR TO THE APONEUROSIS OF THE EXTERNAL OBLIQUE, WHICH WAS BIOPSIED. THE ILIOINGUINAL NERVE WAS IDENTIFIED AND PRESERVED. THE CONTENTS OF INGUINAL CANAL AND A LARGE DIRECT INGUINAL HERNIA WAS IDENTIFIED. A PLUG WAS PLACED TO THE PUBIS MEDIALLY AND THE PATCH WAS PLACED TO PUBIS WITH TAILS AROUND THE CORD.¿ ON (B)(6) 2005 - PATIENT VISITED HOSPITAL FOR PAIN, ERYTHEMA AND HEMATOMA AT THE SITE OF INGUINAL HERNIA REPAIR. ON (B)(6) 2005 - PATIENT VISITED HOSPITAL FOR ABDOMINAL PAIN AND WAS DIAGNOSED WITH EPIDIDYMITIS. ON (B)(6) 2005 - PATIENT HAD COLONOSCOPY FOR INTERNAL HEMORRHOIDS. ON (B)(6) 2017 - PATIENT UNDERWENT REMOVAL SURGERY. (NOTE, NO OP NOTES WERE PROVIDED IN MEDICAL RECORDS.)

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2005: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA. AS REPORTED, A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER (B)(4), LOT NUMBER 43EPD128 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2017: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND "REMOVE IT." AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE PERFIX PLUG.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. TO DATE NO MEDICAL RECORDS HAVE BEEN PROVIDED. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND "REMOVE IT." MEDICAL RECORDS WERE NOT PROVIDED AND THE DESCRIPTION DOES NOT CLEARLY DEFINE WHAT "REMOVE IT" IS REFERRING TO (EXAMPLE POSSIBLE MESH EXPLANT, PARTIAL EXPLANT, OR REMOVAL/REPAIR OF THE HERNIA DEFECT ITSELF WITHOUT EXPLANT OF PREVIOUSLY PLACED MESH). AS SUCH AT THIS TIME, WE HAVE NOT IDENTIFIED THIS AS REPORTED DEVICE EXPLANT. IT IS UNCLEAR AT THIS TIME IF THE HERNIA DEFECT REPAIRED POST IMPLANT OF THE MESH WAS A RECURRENCE OF THE ORIGINAL HERNIA DEFECT OR A NEW HERNIA DEFECT, HOWEVER, RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. 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) 2005: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA. AS REPORTED, A BARD/DAVOL PERFIX PLUG, REFERENCE NUMBER 0112770, LOT NUMBER 43EPD128 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2017: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND "REMOVE IT." AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE PERFIX PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116365 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43EPD128 00801741016615

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Disability| R