BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET,MENISCUS MENDER II DISPOSABLE

    MDR report key: 7050718 · Received November 21, 2017

    Report

    Report Number
    1219602-2017-01450
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    November 13, 2017
    Report Date
    January 4, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWQ
    UDI-DI
    03596010468482
    PMA / PMN Number
    K885311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DUE NO PRODUCT RETURN, THE COMPLAINT COULD NOT BE CONFIRMED. DEFINITIVE CONCLUSIONS CANNOT BE MADE WITHOUT A DEVICE TO EVALUATE. ACCURATE INVESTIGATION AND EVALUATION ARE NOT POSSIBLE. THE PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION. NO FURTHER ACTIONS PURSUED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOOP OF THE SET MENISCUS MENDER II KEPT BREAKING. ALSO, THEY ARE NO LONGER SHARP LIKE THEY USED TO BE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829787 SET,MENISCUS MENDER II DISPOSABLE PASSER HWQ SMITH & NEPHEW, INC. 7209485 50673861 03596010468482

    Patients

    Seq Age Sex Outcome Treatment
    1