BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMED DORO SKULL CLAMP

    MDR report key: 9915832 · Received April 1, 2020

    Report

    Report Number
    MW5094024
    Event Type
    Injury
    Date Received
    April 1, 2020
    Date of Event
    March 18, 2020
    Report Date
    March 31, 2020
    Manufacturer
    UNK
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DORO SKULL CLAMP SLIPPED AFTER PT PINNED/PLACED IN MAYFIELD BASE UNIT. PT SAFELY RETURNED TO STRETCHER. CLAMP REMOVED FROM PT. THREE MM LACERATION NOTED ON SCALP; PROMED INSTRUMENTS, INC., (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372672 PROMED DORO SKULL CLAMP HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) HBL UNK 100.001

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention