BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM FFB WH 2 HC-5 IN 40" SUTURE

    MDR report key: 1881776 · Received October 8, 2010

    Report

    Report Number
    3004365956-2010-00294
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE DISTRIBUTOR, CONMED, REC'D A COMPLAINT THAT 1 OF 12 SUTURE POUCHES IN A BOX HAD A BREECH IN THE POUCH SEAL. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OEM FFB WH 2 HC-5 IN 40" SUTURE SUTURE GAO TELEFLEX MEDICAL NA 1208288E10

    Patients

    Seq Age Sex Outcome Treatment
    1