BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEG HOLDER, PAIR

    MDR report key: 8412495 · Received March 12, 2019

    Report

    Report Number
    8010652-2019-00011
    Event Type
    Injury
    Date Received
    March 12, 2019
    Date of Event
    March 1, 2019
    Report Date
    June 11, 2019
    Manufacturer
    HOLGER ULLRICH
    Product Code
    BWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET GMBH, KEHLER STRASSE 31, RASTATT, GERMANY 76437. EXEMPTION # E2018004. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). AT THE TIME OF THIS REPORT THE INVESTIGATION WAS STILL ONGOING. AS SOON AS THE INVESTIGATION IS FINISHED THE REPORT WILL BE UPDATED AND A FOLLOW-UP/FINAL REPORT WILL BE PROVIDED TO THE FDA.

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET GMBH. (B)(4). EXEMPTION # E2018004. (B)(4). A GETINGE-MAQUET SERVICE TECHNICIAN VISITED THE CUSTOMER AND INVESTIGATED THE PRODUCT IN QUESTION. NO MALFUNCTION OR DEFECT COULD BE FOUND. THE USER STATED THAT THE DEVICE HAS MOVED DURING OPERATION. THE DESCRIBED MOVEMENTS CAN BE RELEASED BY OPENING A LOCKING HANDLE. IN THE INSTRUCTIONS FOR USE (IFU) THE USER IS TOLD TO ENSURE THAT THE LEG HOLDER IS PROPERLY SEATED AFTER ADJUSTING IT. FURHTER THE USER IS WARNED CONCERNING THE RISKS RELATED TO LOOSE OR LOOSENED SECURING ELEMENTS. QUOTE IFU: "RISK OF INJURY! LOOSE OR LOOSENED SECURING ELEMENTS MAY CAUSE INJURIES. WHEN APPLYING, AND AFTER EVERY ADJUSTMENT PROCESS, TIGHTEN ALL SECURING ELEMENTS OF THE PRODUCT FIRMLY (HANDLE SCREWS, CATCHES, LEVERS, ETC.). CHECK THE FIRM SEATING OF THE SECURING ELEMENTS." SINCE NO MALFUNCTION OR DAMAGE COULD BE FOUND WE ASSUME THAT THE LOCKING HANDLE WAS EATHER NOT TIGHTENED PROPERLY OR ACCIDENTLY RELEASED. THE CUSTOMER REFUSED TO PROVIDE FURTHER INFORMATION CONCERNING THE PATIENT STATUS. GETINGE-MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN INCIDENT WITH A LEG HOLDER. THIS RESULTED IN THE PATIENT'S FOOT TO BE INJURED. FURTHER DETAILS REGARDING THIS EVENT WERE REQUESTED, BUT ARE NOT YET AVAILABLE AT THE DATE OF THIS REPORT. (B)(4).

    Description of Event or Problem · 0

    THE PRODUCT WAS INVESTIGATED BY A GETINGE MAQUET SERVICE TECHNICIAN AND NO MALFUNCTION OR DAMAGE WAS FOUND. MANUFACTURER REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206261 LEG HOLDER, PAIR TABLE AND ATTACHMENTS, OPERATING-ROOM BWN HOLGER ULLRICH 100586B0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other