BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 8015557 · Received October 29, 2018

    Report

    Report Number
    1213643-2018-03780
    Event Type
    Injury
    Date Received
    October 29, 2018
    Date of Event
    August 27, 2016
    Report Date
    October 1, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME NO CONCLUSIONS CAN BE MADE. NO LOT NUMBER HAS BEEN PROVIDED THEREFORE A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. THERE AN ALLEGATION OF ADDITIONAL MEDICAL TREATMENT HOWEVER,NO MEDICAL RECORDS HAVE BEEN PROVIDED. INFORMATION IS LIMITED AT THIS TIME. ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT DATE OF IMPLANT. ROOT CAUSE IS INCONCLUSIVE; NO CONCLUSION CAN BE MADE AS TO THE EXTENT TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE. 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) 2013: THE PATIENT WAS DIAGNOSED WITH A VENTRAL HERNIA. (B)(6) 2016: THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR WITH A BARD/DAVOL BARD FLAT MESH PRODUCT. AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING AND MENTAL ANGUISH, HAS SUSTAINED PERMANENT INJURY, HAD UNDERGONE MEDICAL TREATMENT AND WILL LIKELY UNDERGO FURTHER MEDICAL TREATMENT AND PROCEDURES. IT IS ALLEGED THAT THE BARD/DAVOL FLAT MESH IS DEFECTIVE. THE PATIENT HAS EXPERIENCED MENTAL AND PHYSICAL PAIN AND SUFFERING HAS SUSTAINED PERMANENT INJURY, HAS UNDERGONE MEDICAL TREATMENT AND/OR CORRECTIVE SURGERY AND HOSPITALIZATION. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT UNDERWENT HERNIA REPAIR WITH THE IMPLANT OF UNSPECIFIED BARD FLAT MESH. (NOTE: THERE IS NO OPERATIVE NOTES AND PRODUCT IDENTIFIER PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORD). (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH PARTIAL BOWEL OBSTRUCTION, ILLEAL POUCHITIS THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF UNKNOWN MESH. PER OPERATIVE NOTES, ¿THE MIDLINE SCAR WAS EXCISED. LYSIS OF ADHESION WAS PERFORMED TO PEEL OFF THE ADHESION AND TRANSECTING THE MESH AND FASCIA ALL WAY DOWN TO PUBIS. IN RIGHT LOWER QUADRANT, THE BOWEL WAS PLASTERING TIGHTLY TO THE PIECE OF MESH. THE UNKNOWN MESH WAS PEELED OFF. TERMINAL ILEUM ON TOP OF ILEAL POUCH WAS TRANSECTED. THE MIDLINE MESH WAS RESUTURED.¿ (NOTE: THE MESH EXPLANTED IN THIS PROCEDURE WAS UNKNOWN). (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH PELVIS ABSCESS THEREBY UNDERWENT DRAINAGE OF ABSCESS. (B)(6) 2016 - PATIENT UNDERWENT EXPLORATORY LAPAROTOMY AND EXPLANT OF UNSPECIFIED BARD MESH. (NOTE: THERE IS NO OPERATIVE NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORD).

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO CONCLUSIONS CAN BE MADE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. THERE AN ALLEGATION OF ADDITIONAL MEDICAL TREATMENT; HOWEVER, NO MEDICAL RECORDS HAVE BEEN PROVIDED. INFORMATION IS LIMITED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2013: THE PATIENT WAS DIAGNOSED WITH A VENTRAL HERNIA. ON (B)(6) 2016: THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR WITH A BARD/DAVOL BARD FLAT MESH PRODUCT. AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING AND MENTAL ANGUISH, HAS SUSTAINED PERMANENT INJURY, HAD UNDERGONE MEDICAL TREATMENT AND WILL LIKELY UNDERGO FURTHER MEDICAL TREATMENT AND PROCEDURES. IT IS ALLEGED THAT THE BARD/DAVOL FLAT MESH IS DEFECTIVE. THE PATIENT HAS EXPERIENCED MENTAL AND PHYSICAL PAIN AND SUFFERING HAS SUSTAINED PERMANENT INJURY, HAS UNDERGONE MEDICAL TREATMENT AND/OR CORRECTIVE SURGERY AND HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854196 BARD FLAT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Disability| R