BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLSOFT

    MDR report key: 13007987 · Received December 15, 2021

    Report

    Report Number
    9612515-2021-00029
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    November 8, 2021
    Report Date
    January 14, 2022
    Manufacturer
    VASCUTEK LTD
    Product Code
    DXZ
    UDI-DI
    05037881010656
    PMA / PMN Number
    K963611
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION FINDINGS - 213 - NO DEVICE PROBLEM WAS FOUND. VASCUTEK LTD COMPLETED REVIEW OF THE ASSOCIATED MANUFACTURING AND STERILISATION RECORDS FOR THESE DEVICES; ALL RECORDS INDICATE THAT THEY WERE MANUFACTURED AND PROCESSED AS PER SPECIFICATIONS. INVESTIGATION CONCLUSION - 4315 - CAUSE NOT ESTABLISHED - FOR THE FOLLOWING REASONS 1. THE INVESTIGATION CONDUCTED BY VASCUTEK LTD. CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. 2. THE REPORTING SITE TESTED THE PATIENT FOR SIGNS OF INFECTION; NONE WAS FOUND. 3. THE REPORTING SITE INDICATED THAT SOME REDNESS IS STILL PRESENT AT THE WOUND BUT IS NOT CLINICALLY SIGNIFICANT. WOUND HEALING IS GOOD AND ANTIBIOTICS HAVE BEEN STOPPED 4. REVIEW OF THE SUPPLIED IFU BOOKLET WITH THIS DEVICE TYPE INDICATES THAT FEVER AND LOCALISED INFLAMMATION OF SURGICAL SITES ARE A KNOWN AND EXPECTED OUTCOME/ADVERSE EVENT ASSOCIATED WITH THE IMPLANTATION OF GELSOFT BRANDED GRAFTS. VASCUTEK CONSIDERS THIS EVENT AS CLOSED AS NO FURTHER INVESTIGATION IS POSSIBLE. FURTHER ACTION IS NOT PLANNED, HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ON-GOING COMPLAINTS TRENDING AND REPORTING PROCESS AND IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    THIS EVENT WAS REPORTED VIA THE PANTHER STUDY. REPORTED WOUND COMPLICATIONS FOLLOWING IMPLANTATION OF A CARDIOVASCULAR PATCH IN THE FEMORAL AREA. THE SITE REPORTED POSSIBLE INFECTION DESPITE NEGATIVE TEST RESULTS BY THE SITES LAB TESTING.

    Description of Event or Problem · 0

    THIS EVENT WAS REPORTED VIA THE PANTHER STUDY REPORTED WOUND COMPLICATIONS FOLLOWING IMPLANTATION OF A CARDIOVASCULAR PATCH IN THE FEMORAL AREA. THE SITE REPORTED POSSIBLE INFECTION DESPITE NEGATIVE TEST RESULTS BY THE SITES LAB TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908958 GLSOFT GELSOFT PATCH DXZ VASCUTEK LTD GELSOFT PATCH 18066428 05037881010656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other