BEUDAMED
    FDA Adverse Event Summary report: N

    PENTAX

    MDR report key: 5300196 · Received December 15, 2015

    Report

    Report Number
    9610877-2015-00074
    Date Received
    December 15, 2015
    Report Date
    December 15, 2015
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE) INFECTIONS ARISING OUT OF (B)(6), WERE THE SUBJECT OF MULTIPLE PREVIOUS MDRS (MDR#'S 2518897-2013-00004, 2518897-2013-00005, 2518897-2013-00006, 2518897-2014-00001, AND 2518897-2014-00002 FILED ON 09/20/2013, 10/28/2013, 11/12/2013, 03/06/2014, 03/06/2014, RESPECTIVELY). PENTAX OF AMERICA, INC. FILED THE 5 MDRS MENTIONED ABOVE BASED ON THE DUODENOSCOPE ALLEGEDLY INVOLVED IN THE EVENT. THE MDRS INCLUDED INFORMATION ON EACH OF THE THIRTY-SEVEN PATIENTS ON THE INDIVIDUAL FORMS ASSOCIATED WITH THE RELEVANT DUODENOSCOPE-SPECIFIC MDR. HOWEVER, EACH PATIENT DID NOT HAVE A UNIQUE MDR NUMBER. TO ENSURE FULL COMPLIANCE WITH FDA'S EXPECTATION OF ONE PATIENT PER NUMBER, PENTAX OF AMERICA, INC. IS SUBMITTING ADDITIONAL MDRS TO ENSURE EACH PATIENT IS UNIQUELY IDENTIFIED/REPORTED. MDR 9610877-2015-00074 IS BEING SUBMITTED TO ENSURE PATIENT (B)(6) IS UNIQUELY IDENTIFIED/REPORTED. GOING FORWARD, PENTAX MEDICAL WILL REPORT SUPPLEMENTAL INFORMATION ON THIS PATIENT EXCLUSIVELY TO THIS MDR. MDR 2518897-2014-00001 INCLUDES INFORMATION PREVIOUSLY REPORTED ON THE PATIENT IDENTIFIED IN THIS MDR ((B)(6)) AND ON THE DEVICE INVOLVED IN THE EVENT (VIDEO DUODENOSCOPE ED-3490TK/SERIAL (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826278 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1