BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 7525660 · Received May 18, 2018

    Report

    Report Number
    1213643-2018-01587
    Event Type
    Injury
    Date Received
    May 18, 2018
    Report Date
    May 22, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD FLAT MESH MAY HAVE CAUSED OR CONTRIBUTED TO THE RECURRENT HERNIAS. TABLE 2 OF THE ARTICLE IDENTIFIES SOME PATIENT'S EXPERIENCED THE FOLLOWING CONDITIONS; AWARENESS OF GROIN LUMP, PERCEPTION OF FOREIGN MATERIAL IN GROIN, LOSS OF SKIN SENSATION IN GROIN, DISCOMFORT IN GROIN. BASED ON THE INFORMATION PROVIDED IN THE JOURNAL ARTICLE 4 MALE STUDY PATIENTS PREVIOUSLY IMPLANTED WITH BARD FLAT MESH EXPERIENCED A HERNIA RECURRENCE. THE IMPLANT DATES VARY BETWEEN JANUARY 2007 AND OCTOBER 2009. THE INFORMATION IS LIMITED TO THE ARTICLE AT THIS TIME. HERNIA RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY. REGARDING RECURRENCES THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE, PROVIDED WITH THE DEVICE, STATES, "TO PREVENT RECURRENCES WHEN REPAIRING HERNIAS, THE PROSTHESIS SHOULD BE LARGE ENOUGH TO EXTEND BEYOND THE MARGINS OF THE DEFECT. WHEN REPAIRING INGUINAL HERNIAS THE MESH SHOULD BE LARGE ENOUGH TO EXTEND BEYOND THE PUBIC TUBERCLE AND SHOULD FIT SECURELY AROUND THE SPERMATIC CORD AT THE INTERNAL RING." ADDITIONALLY, THE ADVERSE REACTION SECTION LISTS RECURRENCE AS A POSSIBLE COMPLICATION. WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. ADDITIONAL INFORMATION: THIS FOLLOW UP TO THE INITIAL EMDR IS TO DOCUMENT ADDITIONAL INFORMATION FROM THE ARTICLE. TABLE 2 OF THE ARTICLE IDENTIFIES SOME PATIENT'S EXPERIENCED THE FOLLOWING CONDITIONS; AWARENESS OF GROIN LUMP, PERCEPTION OF FOREIGN MATERIAL IN GROIN, LOSS OF SKIN SENSATION IN GROIN, DISCOMFORT IN GROIN. AT THIS TIME, WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD FLAT MESH MAY HAVE CAUSED OR CONTRIBUTED TO THESE CONDITIONS. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED VIA JOURNAL ARTICLE (THIS ARTICLE IS AN OPEN ACCESS PUBLICATION. PUBLISHED ON LINE 20 JAN 2018, HTTPS://DOI.ORG/10.1007/S10029-018-1734-Z): TITLE: "CHRONIC PAIN, DISCOMFORT, QUALITY OF LIFE AND IMPACT ON SEX LIFE AFTER OPEN INGUINAL HERNIA MESH REPAIR: AN EXPERTISE BASED RANDOMIZED CLINICAL TRIAL COMPARING LIGHTWEIGHT AND HEAVYWEIGHT MESH." THE "HEAVYWEIGHT MESH" USED IN THE STUDY WAS A BARD FLAT MESH. THE IMPLANT PROCEDURES WERE PERFORMED FROM JANUARY 2007 TO OCTOBER 2009. THE LAST FOLLOW-UP VISIT WAS IN SEPTEMBER 2011. THE STUDY IDENTIFIED THE RECURRENCE RATE TO BE 2.4% AND EQUAL BETWEEN GROUPS, I.E., 4 RECURRENCES IN EACH GROUP. AS SUCH FOUR PATIENT'S TREATED WITH BARD FLAT MESH EXPERIENCED A RECURRENCE. NO CAUSE FOR THE RECURRENCES IS IDENTIFIED AND NO TREATMENT, MEDICAL, SURGICAL INTERVENTION IS LISTED. TABLE 2 OF THE ARTICLE IDENTIFIES SOME PATIENT'S EXPERIENCED THE FOLLOWING CONDITIONS; AWARENESS OF GROIN LUMP, PERCEPTION OF FOREIGN MATERIAL IN GROIN, LOSS OF SKIN SENSATION IN GROIN, DISCOMFORT IN GROIN.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD FLAT MESH MAY HAVE CAUSED OR CONTRIBUTED TO THE RECURRENT HERNIAS. BASED ON THE INFORMATION PROVIDED IN THE JOURNAL ARTICLE 4 MALE STUDY PATIENTS PREVIOUSLY IMPLANTED WITH BARD FLAT MESH EXPERIENCED A HERNIA RECURRENCE. THE IMPLANT DATES VARY BETWEEN JANUARY 2007 AND OCTOBER 2009. THE INFORMATION IS LIMITED TO THE ARTICLE AT THIS TIME. HERNIA RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY. REGARDING RECURRENCES THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE, PROVIDED WITH THE DEVICE, STATES, "TO PREVENT RECURRENCES WHEN REPAIRING HERNIAS, THE PROSTHESIS SHOULD BE LARGE ENOUGH TO EXTEND BEYOND THE MARGINS OF THE DEFECT. WHEN REPAIRING INGUINAL HERNIAS THE MESH SHOULD BE LARGE ENOUGH TO EXTEND BEYOND THE PUBIC TUBERCLE AND SHOULD FIT SECURELY AROUND THE SPERMATIC CORD AT THE INTERNAL RING." ADDITIONALLY, THE ADVERSE REACTION SECTION LISTS RECURRENCE AS A POSSIBLE COMPLICATION. WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. 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. NO SAMPLE.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED VIA JOURNAL ARTICLE (THIS ARTICLE IS AN OPEN ACCESS PUBLICATION. PUBLISHED ON LINE 20 JAN 2018, HTTPS://DOI.ORG/10.1007/S10029-018-1734-Z): TITLE: "CHRONIC PAIN, DISCOMFORT, QUALITY OF LIFE AND IMPACT ON SEX LIFE AFTER OPEN INGUINAL HERNIA MESH REPAIR: AN EXPERTISE BASED RANDOMIZED CLINICAL TRIAL COMPARING LIGHTWEIGHT AND HEAVYWEIGHT MESH." THE "HEAVYWEIGHT MESH" USED IN THE STUDY WAS A BARD FLAT MESH. THE IMPLANT PROCEDURES WERE PERFORMED FROM JANUARY 2007 TO OCTOBER 2009. THE LAST FOLLOW-UP VISIT WAS IN (B)(6) 2011. THE STUDY IDENTIFIED THE RECURRENCE RATE TO BE 2.4% AND EQUAL BETWEEN GROUPS, I.E., 4 RECURRENCES IN EACH GROUP. AS SUCH FOUR PATIENT'S TREATED WITH BARD FLAT MESH EXPERIENCED A RECURRENCE. NO CAUSE FOR THE RECURRENCES IS IDENTIFIED AND NO TREATMENT, MEDICAL, SURGICAL INTERVENTION IS LISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367638 BARD FLAT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention