BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELWEAVE

    MDR report key: 12745163 · Received November 3, 2021

    Report

    Report Number
    9612515-2021-00023
    Event Type
    Injury
    Date Received
    November 3, 2021
    Date of Event
    September 10, 2021
    Report Date
    November 3, 2021
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881120133
    PMA / PMN Number
    K013022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). VASCUTEK LTD. CONSIDERS THIS EVENT AS CLOSED. FURTHER ACTION IS NOT PLANNED, HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED ASAS PART OF THE ON-GOING COMPLAINTS TRENDING AND REPORTING PROCESS AND IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME.

    Description of Event or Problem · 0

    EVENT WAS REPORTED TO VASCUTEK LTD VIA CLINICAL TRIAL AS ALLERGIC REACTION TO GELATIN/POLYESTER. CLINICIAN INDICATED THIS EVENT WAS NOT DEVICE RELATED. (B)(6) 2021 : HYPOTENSION AFTER SURGICAL STERNUM CLOSURE DUE TO VASOPLEGIA CAUSED BY AN ALLERGIC REACTION REPEAT STERNOTOMY FOR VISUAL INSPECTION PERFORMED, TRENDELENBURG POSITION + FEMORAL ARTERIAL CATHETER FOR HEMODYNAMIC CONTROL EVENT RESOLVED ON (B)(6) 2021. (B)(6) 2021 : URTICARIAL RASH RESOLVED WITH MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1646547 GELWEAVE GELWEAVE VALSALVA DSY VASCUTEK LTD GELWEAVE VALSALVA 21872544 05037881120133

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention