BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET

    MDR report key: 1671880 · Received April 26, 2010

    Report

    Report Number
    8010652-2010-00005
    Event Type
    Injury
    Date Received
    April 26, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 11, 2010
    Manufacturer
    MAQUET GMBH & CO. KG
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THIS INCIDENT IS COMPRISED OF TWO PARTS (CLAMP - PRODUCT CODE HBL & TABLE ADAPTER - PRODUCT CODE FWZ). THE CLAMP IS PRODUCED BY INTEGRA LIFESCIENCES CORP FOR MAQUET GMBH AND THE TABLE ADAPTER IS PRODUCTED BY MAQUET (B) (4). BASED ON THE INFO RECEIVED TO DATE, IT IS NOT CLEAR WHETHER THE ADAPTER CONTRIBUTED TO THE INCIDENT. THE DEVICE WAS RETURNED TO MAQUET (B) (4) AND AN INVESTIGATION IS CURRENTLY BEING PERFORMED BY MAQUET (B) (4) IN CONJUNCTION WITH INTEGRA. MAQUET INC SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET (B) (4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED MAQUET INC TO REPORT THAT DURING SURGERY THE PT'S HEAD SLIPPED OUT OF THE SKULL CLAMP RESULTING IN TWO LACERATIONS. THE CUSTOMER DID NOT INDICATE THE SEVERITY OF THE REPORTED INJURIES. (B) (4). (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET MAYFIELD SKULL CLAMP HBL MAQUET GMBH & CO. KG 1005.57AO

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other