BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO (R)

    MDR report key: 6607244 · Received June 2, 2017

    Report

    Report Number
    3003923584-2017-00007
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    December 6, 2016
    Report Date
    May 8, 2017
    Manufacturer
    PRO MED INSTRUMENTS
    Product Code
    HBL
    PMA / PMN Number
    K032331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    RESPONSE TO FDA NOTICE TO USER FACILITY REPORT MW5069342. WE ARE NOT ABLE TO RELATE A DEVISE TO THE REPORTED INCIDENT (SN OF THE INVOLVED DEVICE WAS NOT PROVIDED). WE ASKED CUSTOMER FOR ADDITIONAL INFORMATION ABOUT THE INVOLVED DEVICE BUT DID NOT RECEIVE ANY INFORMATION.

    Description of Event or Problem · 1

    PMI INC RECEIVED FDA NOTICE TO USER FACILITY REPORT MW5069342. CUSTOMER STATED AN INCIDENT HAPPENED AT (B)(6) 2016. "DURING SPINAL SURGERY AND UPON RETURNING THE PATIENT TO PRONE POSITION, THE DORO HEAD CLAMP DISPLACED CAUSING LACERATION NEAR THE PIN SITE. THE PIN SITES WERE STAPLED CLOSED. " WE NEVER RECEIVED ANY INFORMATION TO THESE INCIDENT BEFORE 05/08/2017. WE ASKED CUSTOMER FOR SN OF THE INVOLVED DEVICE BUT DID NOT RECEIVE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389319 DORO (R) SKULL CLAMP HBL PRO MED INSTRUMENTS 3034-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention