BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIO ADULT

    MDR report key: 17955290 · Received October 18, 2023

    Report

    Report Number
    9616791-2023-00003
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    August 15, 2023
    Report Date
    October 15, 2023
    Manufacturer
    WAISMED LTD
    Product Code
    FMI
    PMA / PMN Number
    K142086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS BEEN CONTACTED SEVERAL TIMES IN AN ATTEMPT TO OBTAIN ADDITIONAL DETAILS CONCERNING THE DEVICE INVOLVED IN THE REPORTED EVENT. UNFORTUNATELY, WE HAVE NOT RECEIVED ANY CLARIFICATION OR FURTHER INFORMATION REGARDING THE EVENT.WE HAVE ALSO REQUESTED CLARIFICATION CONCERNING THE SENTENCE MENTIONED IN THE CUSTOMER'S ORIGINAL REPORT REGARDING "MULTIPLE FAILURES". HOWEVER, WE HAVE NOT YET RECEIVED A RESPONSE.

    Description of Event or Problem · 0

    COMPLAINT DESCRPTION FROM CUSTOMER ON (B)(6) 2023. "CUSTOMER IS STATING THAT THEY HAVE HAD MULTIPLE FAILURES OF THE DEVICES FAILING TO DEPLOY PROPERLY AND THE HANDLES FALLING APART. THEY ARE GATHERING MORE DETAILS ON MORE SPECIFICS AND ATTEMPTING TO GET PHOTOS. WAS AN INJURY/DEATH INVOLVED: NO_INJURY/DEATH INJURY/DEATH FURTHER INFORMATION:N/A. PRODUCT AVAILABLE FOR RETURN?: NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241860 NIO ADULT INTRAOSSEOUS ACCESS DEVICE FMI WAISMED LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown