BEUDAMED
    FDA Adverse Event Death Summary report: N

    18 MM 30CM HEMASHIELD MDV

    MDR report key: 4987589 · Received August 5, 2015

    Report

    Report Number
    2242352-2015-00666
    Event Type
    Death
    Date Received
    August 5, 2015
    Date of Event
    July 30, 1997
    Report Date
    July 20, 2015
    Manufacturer
    MAQUET CARDIOVASCULAR LLS
    Product Code
    MAL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION; THEREFORE, IT COULD NOT BE EVALUATED. PROVIDED CUSTOMER WITH RESULT FROM REGULATORY THAT NO FIELD ACTIONS HAVE BEEN CONDUCTED ON THIS PRODUCT. REITERATED THAT THIS PRODUCT IS A GRAFT AND NOT MESH PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE (B)(4) SPOKE WITH CONSUMER ON 22JUL2015 AT 10:31 - THE CUSTOMER WAS PROVIDED WITH RESULTS FROM REGULATORY THAT NO FIELD ACTIONS HAVE BEEN CONDUCTED ON THIS PRODUCT. IT WAS RE-ITERATED THAT THIS PRODUCT IS A GRAFT AND NOT MESH PRODUCT. CONSUMER THANKED (B)(4) FOR THEIR EFFORT. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    CONSUMER CALLED (B)(4) TO INQUIRE IF A RECALL WAS ISSUED FOR THE MESH PRODUCT WHICH HER HUSBAND RECEIVED DURING SURGERY ON (B)(6) 1997. CONSUMER WAS ADAMANT THAT SHE WANTS ANSWERS TO HER QUESTIONS. IT WAS INDICATED THAT HER HUSBAND RECEIVED AN AORTIC IMPLANT HAS A RESULT OF AN ANEURISM. CONSUMER STATED THAT HER HUSBAND DIED UNDER STRANGE CIRCUMSTANCES. THE WIFE STATES HER HUSBAND SAID HE WAS TIRED AND WENT TO LIE ON THE COUCH, WHERE SHE FOUND HIM DEAD THE NEXT MORNING. CONSUMER'S HUSBAND PASSED AWAY ON (B)(6) 2011. CONSUMER IS EXPECTING AN URGENT RESPONSE FROM THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515623 18 MM 30CM HEMASHIELD MDV VASCUALR GRAFT MAL MAQUET CARDIOVASCULAR LLS 526289

    Patients

    Seq Age Sex Outcome Treatment
    1 Death