BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIAD STERILE LUBRICATING JELLY

    MDR report key: 2040811 · Received March 22, 2011

    Report

    Report Number
    2128643-2011-00018
    Event Type
    Death
    Date Received
    March 22, 2011
    Date of Event
    August 28, 2010
    Report Date
    March 18, 2011
    Manufacturer
    TRIAD
    Product Code
    FHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO PHONE CONVERSATION WITH TRUSTEE/CAREGIVER ((B)(6)), THE DEATH CERTIFICATE STATED SHE DIED OF: SEPTIC SHOCK, MULTIPLE UTIS, CANCER.

    Description of Event or Problem · 1

    RECEIVED MAIL ON (B)(6) 2011 COVER LETTER AND CUSTOMER INCIDENT REPORT DEFECTIVE PRODUCT CLAIM: THE FOLLOWING INFORMATION IS FROM THAT FORM: CUSTOMER HAD RECEIVED INSERTION TRAY THAT WAS RECALLED DUE TO TRIAD LUBRICATING JELLY. NURSE CALLED IN AND SAID SHE JUST GOT A DEFECTIVE LETTER TODAY ((B)(6) 2011) FOR THIS PATIENT THAT PASSED AWAY IN (B)(6) FROM INFECTION. FURTHER INFORMATION RECEIVED VIA PHONE CALL FROM (B)(6) - TRUSTEE FOR ESTATE. SHE DIED (B)(6), 2010 OF SEPTIC SHOCK PROBABLY FROM UTI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAD STERILE LUBRICATING JELLY LUBE JELLY FHX TRIAD

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H COLOPLAST INSERTION TRAY ((B)(4))