BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAMESH IP

    MDR report key: 7062709 · Received November 28, 2017

    Report

    Report Number
    1213643-2017-00930
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    July 14, 2009
    Report Date
    August 12, 2023
    Manufacturer
    GENZYME CORPORATION
    Product Code
    FTL
    UDI-DI
    00801741031816
    PMA / PMN Number
    K063739
    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. BASED ON THE INFORMATION PROVIDED, IT IS UNCLEAR AT THIS TIME IF BOTH SEPRAMESH DEVICES WERE EXPLANTED DURING THE EXCISION PROCEDURE. IT IS ALSO ALLEGED THE PATIENT UNDERWENT REPAIR OF THE RECURRENT HERNIA, 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. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. THIS FILE REPRESENTS SEPRAMESH (DEVICE #1), A SECOND EMDR WILL BE SUBMITTED FOR THE SECOND SEPRAMESH IMPLANTED (DEVICE #2). ADDENDUM: H11: THIS SUPPLEMENTAL MDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT EXPIRY DATE AND MANUFACTURING DATE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO THE INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORD PROVIDED, ABOUT 4 MONTHS POST IMPLANT OF SEPRAMESH IP, PATIENT HAD ADHESIONS, HERNIA RECURRENCE THEREBY UNDERWENT THE REMOVAL OF MESH. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS ADHESIONS AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. CORRECTED FIELDS: D4 (EXPIRY DATE), H4 (MANUFACTURING DATE). THIS SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE SEPRAMESH IP (DEVICE #2). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE SEPRAMESH IP (DEVICE #1). 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 REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2009 - THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA, TWO SEPRAMESH IP MESH DEVICES WERE IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2009 - THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE SEPRAMESH IP AFTER IT HAD FAILED, AND TO REPAIR THE RECURRENT HERNIA. THE ATTORNEY ALLEGES THE PATIENT SUBSEQUENTLY ENDURED ADDITIONAL SURGERIES TO TREAT MESH-RELATED COMPLICATIONS, AND WAS INJURED SEVERELY AND PERMANENTLY. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA AND UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES,"THE HERNIA SAC WAS DISSECTED FREE, 2 PIECES OF SEPRAMESH IP (DEVICE #1, #2) WERE SEWN TOGETHER AND PLACED IN THE FASCIAL DEFECT.¿ ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿HERNIA SAC WAS EXCISED, MESH WAS ADHERENT TO THE FASCIAL EDGES. ON THE LEFT SIDE, THE MESH WAS COMPLETELY REMOVED (DEVICE #1). ON THE RIGHT SIDE, A PORTION OF THE MESH WAS LEFT INTACT (DEVICE #2). THE NEW DEVELOPED (RECURRENT HERNIA) BETWEEN THE SEPARATED 2 PIECES OF MESH WHICH HAD BEEN SEWN TOGETHER BEFORE. ONCE THE HERNIA SAC AND PRIOR MESH WAS COMPLETELY REMOVED, A COMPONENT SEPARATION WAS PERFORMED LATERAL TO THE RECTUS SHEATH ON BOTH SIDES OF THE ABDOMEN. A PIECE OF POLYPROPYLENE MESH WAS THEN SEWN.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ABSCESS, ADHESIONS, FISTULAE, INFECTIONS, PAIN, HERNIA RECURRENCE 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. TO DATE NO MEDICAL RECORDS HAVE BEEN PROVIDED. BASED ON THE INFORMATION PROVIDED, IT IS UNCLEAR AT THIS TIME IF BOTH SEPRAMESH DEVICES WERE EXPLANTED DURING THE EXCISION PROCEDURE. IT IS ALSO ALLEGED THE PATIENT UNDERWENT REPAIR OF THE RECURRENT HERNIA, 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. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. THIS FILE REPRESENTS SEPRAMESH (DEVICE #1), A SECOND EMDR WILL BE SUBMITTED FOR THE SECOND SEPRAMESH IMPLANTED (DEVICE #2). 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.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2009 - THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA, TWO SEPRAMESH IP MESH DEVICES WERE IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2009 - THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE SEPRAMESH IP AFTER IT HAD FAILED, AND TO REPAIR THE RECURRENT HERNIA. THE ATTORNEY ALLEGES THE PATIENT SUBSEQUENTLY ENDURED ADDITIONAL SURGERIES TO TREAT MESH-RELATED COMPLICATIONS, AND WAS INJURED SEVERELY AND PERMANENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843869 SEPRAMESH IP SURGICAL MESH FTL GENZYME CORPORATION 5959480 WBSLS232 00801741031816

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Disability| R