BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGR MATRIX SURGICAL MESH

    MDR report key: 21544979 · Received March 7, 2025

    Report

    Report Number
    3010187263-2025-00001
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    December 21, 2023
    Report Date
    September 17, 2024
    Manufacturer
    NOVUS SCIENTIFIC AB
    Product Code
    OWT
    PMA / PMN Number
    K191749
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE SURGEON (B)(6), SEROMA AND WOUND DEHISCENCE ARE A COMMON POTENTIAL ISSUES WITH THESE SURGERIES AND (B)(6) DOES NOT SPECIFICALLY BLAME TIGR MATRIX FOR THE ISSUE. HE HAS EXPERIENCED THE SAME ISSUE WITH GALAFLEX AND AMDS IN THE PAST. BASED ON THE RECEIVED INFORMATION AND THE FACTS ABOVE IT SEEMS THAT THE REPORTING PATIENT IS MISINFORMED REGARDING THE BELIEF THAT THERE ARE MANY OTHER SAFER MESH AVAILABLE AND THAT THE TIGR MATRIX MESH IS KNOWN TO BE CAUSING ISSUES. THE CURRENT CONCLUSION FROM THE INVESTIGATION BASED ON RECEIVED INFORMATION IS THAT THE TIGR MATRIX MESH IS MOST PROBABLY NOT THE CAUSE FOR THE SEROMA. THE INCIDENT WAS INITIALLY REPORTED BY THE PATIENT TO FDA, SEE MW5157343.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE SURGEON DR (B)(6), SEROMA AND WOUND DEHISCENCE ARE A COMMON POTENTIAL ISSUES WITH THESE SURGERIES AND DR (B)(6) DOES NOT SPECIFICALLY BLAME TIGR MATRIX FOR THE ISSUE. HE HAS EXPERIENCED THE SAME ISSUE WITH GALAFLEX AND AMDS IN THE PAST. BASED ON THE RECEIVED INFORMATION AND THE FACTS ABOVE IT SEEMS THAT THE REPORTING PATIENT IS MISINFORMED REGARDING THE BELIEF THAT THERE ARE MANY OTHER SAFER MESH AVAILABLE AND THAT THE TIGR MATRIX MESH IS KNOWN TO BE CAUSING ISSUES. THE CURRENT CONCLUSION FROM THE INVESTIGATION BASED ON RECEIVED INFORMATION IS THAT THE TIGR MATRIX MESH IS MOST PROBABLY NOT THE CAUSE FOR THE SEROMA. THE INCIDENT WAS INITIALLY REPORTED BY THE PATIENT TO FDA, SEE MW5157343. THIS INCIDENT HAS PREVIOUSLY BEEN REPORTED BY THE US IMPORTER OF TIGR SURGICAL MESH IN US, GLOBAL MEDICAL PARTNER. THIS REPORT FROM THE MANUFACTURER WAS MISTAKENLY NOT RECEIVED BY FDA AT THE SAME TIE DUE TO MISUNDERSTANDING OF THE ESG AND WEBTRADER. THE MISTAKE WAS FOUND WHEN SEARCHING THE MAUDE DATABASE FOR THE YEARLY CLINICAL EVALUATION OF TIGR MATRIX SURGICAL MESH. THE REPORT WAS SUBMITTED BUT REJECTED DUE TO WRONG CODE GIVEN BY MISTAKE WHICH HAS FURTHER DELAYED THE SUBMISSION.

    Description of Event or Problem · 0

    MDR REPORT MW5157343 WAS RECEIVED FROM FDA WHICH HAS RECEIVED THE INCIDENT REPORT FROM THE PATIENT. THE FOLLOWING DESCRIPTION OF THE INCIDENT WAS GIVEN FROM THE PATIENT: "COMPLICATIONS FROM THE TIGR MATRIX SURGICAL MESH THAT WAS USED AS INTERNAL BRA DURING BREAST LIFT SURGERY. I INITIALLY DEVELOPED A SEROMA IN BOTH BREASTS WITHIN A DAY OR TWO AFTER SURGERY. MY INCISION THEN SEPARATED UNDERNEATH BREASTS IN MULTIPLE AREAS, WITH PIECES OF MESH PROTRUDING OUT OF EACH OPEN AREA. THIS HAS CAUSED A LENGTHY RECOVERY WITH EXTENDED FOLLOW UP CARE. WILL NEED TO HAVE SCAR REVISION SURGERY IN THE FUTURE. THESE EVENTS HAVE ADDED ADDITIONAL COST TO ME FOR MEDICATIONS, DRESSINGS, AND DOCTOR VISITS, JUST TO NAME A FEW. MY ORIGINAL SURGERY WAS ON (B)(6) 2023 AND I CONTINUE TO HAVE AREAS THAT REMAIN OPEN AS OF TODAY'S DATE. IT IS ALSO MY UNDERSTANDING THAT I AM NOT THE FIRST PATIENT TO HAVE THESE SAME EXACT ISSUES WITH THIS PARTICULAR MESH. SO, I AM CONFUSED AS TO WHY IT IS STILL BEING USED WHEN THERE ARE MANY OTHER PROVEN SAFER MESH'S AVAILABLE. ALSO, I WONDER WHY I WAS NOT TOLD OF THESE ISSUES AHEAD OF TIME AND BEEN GIVEN A CHOICE FOR ANOTHER OPTION. IF I HAD KNOWN THIS PARTICULAR MESH WAS KNOWN TO BE CAUSING ISSUES, I WOULD HAVE SAVED MYSELF THAT EXTRA EXPENSE AND DECLINED THE MESH. BOTTOM LINE IS, THIS BECOMES AN ISSUE OF IMPROPER "INFORMED CONSENT". ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 30-AUG-2024, FOR MW5157343. WANT TO ADD CURRENT PICTURES AS OF 30-AUG-2024) TO MY PREVIOUSLY SUBMITTED REPORT. FROM THE SURGEON (B)(6) AND WOUND DEHISCENCE ARE A COMMON POTENTIAL ISSUES WITH THESE SURGERIES AND SO HE DOES NOT SPECIFICALLY BLAME TIGR MATRIX FOR THE ISSUE. HE HAS EXPERIENCED THE SAME ISSUE WITH OTHER PRODUCTS IE GALAFLEX AND AMDS IN THE PAST.

    Description of Event or Problem · 0

    MDR REPORT MW5157343 WAS RECEIVED FROM FDA WHICH HAS RECEIVED THE INCIDENT REPORT FROM THE PATIENT. THE FOLLOWING DESCRIPTION OF THE INCIDENT WAS GIVEN FROM THE PATIENT: "COMPLICATIONS FROM THE TIGR MATRIX SURGICAL MESH THAT WAS USED AS INTERNAL BRA DURING BREAST LIFT SURGERY. I INITIALLY DEVELOPED A SEROMA IN BOTH BREASTS WITHIN A DAY OR TWO AFTER SURGERY. MY INCISION THEN SEPARATED UNDERNEATH BREASTS IN MULTIPLE AREAS, WITH PIECES OF MESH PROTRUDING OUT OF EACH OPEN AREA. THIS HAS CAUSED A LENGTHY RECOVERY WITH EXTENDED FOLLOW UP CARE. WILL NEED TO HAVE SCAR REVISION SURGERY IN THE FUTURE. THESE EVENTS HAVE ADDED ADDITIONAL COST TO ME FOR MEDICATIONS, DRESSINGS, AND DOCTOR VISITS, JUST TO NAME A FEW. MY ORIGINAL SURGERY WAS ON (B)(6) 2023 AND I CONTINUE TO HAVE AREAS THAT REMAIN OPEN AS OF TODAY'S DATE. IT IS ALSO MY UNDERSTANDING THAT I AM NOT THE FIRST PATIENT TO HAVE THESE SAME EXACT ISSUES WITH THIS PARTICULAR MESH. SO, I AM CONFUSED AS TO WHY IT IS STILL BEING USED WHEN THERE ARE MANY OTHER PROVEN SAFER MESH'S AVAILABLE. ALSO, I WONDER WHY I WAS NOT TOLD OF THESE ISSUES AHEAD OF TIME AND BEEN GIVEN A CHOICE FOR ANOTHER OPTION. IF I HAD KNOWN THIS PARTICULAR MESH WAS KNOWN TO BE CAUSING ISSUES, I WOULD HAVE SAVED MYSELF THAT EXTRA EXPENSE AND DECLINED THE MESH. BOTTOM LINE IS, THIS BECOMES AN ISSUE OF IMPROPER "INFORMED CONSENT". ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON (B)(6) 2024, FOR MW5157343. WANT TO ADD CURRENT PICTURES AS OF ((B)(6) 2024) TO MY PREVIOUSLY SUBMITTED REPORT. FROM THE SURGEON DR (B)(6) SEROMA AND WOUND DEHISCENCE ARE A COMMON POTENTIAL ISSUES WITH THESE SURGERIES AND SO HE DOES NOT SPECIFICALLY BLAME TIGR MATRIX FOR THE ISSUE. HE HAS EXPERIENCED THE SAME ISSUE WITH OTHER PRODUCTS IE GALAFLEX AND AMDS IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492277 TIGR MATRIX SURGICAL MESH TIGR SURGICAL MESH OWT NOVUS SCIENTIFIC AB NSTM1520 167100-01

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention