BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURAY SURGICAL PADDIES 1/2" X 1/2"

    MDR report key: 9569073 · Received January 8, 2020

    Report

    Report Number
    MW5092100
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Date of Event
    December 19, 2019
    Report Date
    January 6, 2020
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    HBA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DURING AN ARTHROPLASTY A DEVICE'S PADDIES WERE COMING OFF OF THE [INVALID]. THIS WAS IDENTIFIED BY AN RN DURING THE PROCEDURE SO IT DID NOT AFFECT OUR PT. THE PRODUCT WAS REF # 800400 NUERAY 200PK 13X13MM PADDIES. LOT NUMBER 00030431. WE HAVE PULLED THE REMAINING PADDIES OFF OF THE SHELF. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29819 NEURAY SURGICAL PADDIES 1/2" X 1/2" NEUROSURGICAL PADDIE HBA MEDTRONIC XOMED, INC. 8004000 00030431

    Patients

    Seq Age Sex Outcome Treatment
    1