BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRIGATINO TUBING AND CLIPS, HI-FLOW

    MDR report key: 3984209 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-14883
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    December 8, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    K063688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED BY DEPUY SYNTHES POWER TOOLS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT WAS RECEIVED FROM (B)(6), STATING THAT THE DEVICE HAD DEBRIS IN THE STERILE PACKAGE THAT WAS OBSERVED DURING SURGERY. NO INJURIES WERE REPORTED TO HAVE OCCURRED, HOWEVER, IT IS UNK IF MEDICAL INTERVENTION WAS NECESSARY. THE DATE OF THE EVENT IS UNK. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664063 IRRIGATINO TUBING AND CLIPS, HI-FLOW HWE DEPUY SYNTHES POWER TOOLS M683360

    Patients

    Seq Age Sex Outcome Treatment
    1 NI