BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEAD PLATE

    MDR report key: 11654335 · Received April 13, 2021

    Report

    Report Number
    8010652-2021-00017
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    April 8, 2021
    Report Date
    October 4, 2021
    Manufacturer
    HOLGER ULLRICH
    Product Code
    BWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE WAS INVESTIGATED BY A GETINGE FIELD SERVICE ENGINEER (FSE). THE FSE DID NOT FIND ANY DAMAGE OR MALFUNCTION ON THE HEAD PLATE. WE ASSUME THAT A USE ERROR CONTRIBUTED TO THIS INJURY. THE USER IS WARNED AS FOLLOWS IN THE INSTRUCTIONS FOR USE (IFU) CONCERNING CRUSHING AND SHEARING HAZARDS: "WARNING! RISK OF INJURY! WHENEVER THE PRODUCT IS MOUNTED AND ADJUSTED, THERE IS A DANGER OF PINCHING AND SHEARING TO THE STAFF, PATIENT AND ACCESSORIES. ALWAYS ENSURE THAT NO ONE CAN BE SUBJECTED TO PINCHING OR SHEARING ACTION OR INJURED IN ANY OTHER WAY AND THAT THE ACCESSORIES DO NOT COLLIDE WITH ANY NEARBY OBJECTS." GETINGE-MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    FURTHER INFORMATION CONCERNING WHERE THE FINGER WAS PINCHED ON THE PRODUCT AND HOW THE MEDICAL OUTCOME OF THIS INJURY WAS, WAS REQUESTED FROM THE CLINIC. THIS INFORMATION WAS NOT PROVIDED BY THE CLINIC. MANUFACTURER REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT THE INVESTIGATION IS STILL ONGOING. WHEN THE INVESTIGATION IS COMPLETED THE REPORT WILL BE UPDATED AND A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED. THE DEVICE WAS LAYING ON THE FLOOR. WHEN A CLEANING STAFF MEMBER PICKED IT UP AFTER THE SURGERY, SHE PINCHED HER FINGER. THE JOINTS OF THE HEAD PLATE MOVED AND THE RIGHT HAND MIDDLE FINGER GOT CAUGHT. TO FREE THE CAUGHT FINGER, THE HEAD PLATE WAS MOUNTED TO THE OR TABLETOP. THE AFFECTED AREA WAS ICE PACKED AND THE INJURED MEMBER GOT PAIN RELIEVER. NO INJURY TO THE BONE OCCURRED. MANUFACTURER REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551626 HEAD PLATE TABLE AND ATTACHMENTS, OPERATING-ROOM BWN HOLGER ULLRICH 113067B0 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other