BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SUTURE PRODUCT

    MDR report key: 2879224 · Received December 7, 2012

    Report

    Report Number
    1219930-2012-00984
    Event Type
    Death
    Date Received
    December 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    COVIDIEN FORMERLY US
    Product Code
    GAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE PROVIDER: COVIDIEN RECEIVED A REPORT THAT THE TRUST HAD A PATIENT FATALITY AS A RESULT OF A SUTURE THAT HAD SNAPPED POST OPERATIVELY. NO INFORMATION WAS SUPPLIED REGARDING THE NAME OF TH SURGEON, PROCEDURE TYPE OF ANY OTHER DETAILS. SUBSEQUENTLY, THE REPORTER INFORMED COVIDIEN THAT THERE IS NO INFORMATION SUPPORTING ANY POTENTIAL INCIDENT RELATING TO COVIDIEN SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SUTURE PRODUCT SUTURE GAW COVIDIEN FORMERLY US

    Patients

    Seq Age Sex Outcome Treatment
    1 Death