BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERINEAL PAD SUPINE

    MDR report key: 6970308 · Received October 23, 2017

    Report

    Report Number
    3003604053-2017-00314
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    May 18, 2017
    Report Date
    November 15, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KQZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE REASSESSMENT DETERMINED THAT THE ISSUE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. THE ADDITIONAL INFORMATION RECEIVED WAS: REPORT IT TO THE FDA WAS NOT REQUIRED BASED ON THE FACT THAT BRUISING IS AN ANTICIPATED CONDITION THAT CAN BE EXPERIENCED FROM ORTHOPEDIC SURGICAL PROCEDURES.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICE IN QUESTION HAS NOT BEEN RETURNED FOR EVALUATION. THUS, THE COMPLAINT COULD NOT BE VERIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE. IT IS DIFFICULT TO PERFORM AN ACCURATE EVALUATION OF A FAILURE WITHOUT HAVING THE FAILED PRODUCT TO LOOK AT. AS SUCH THE COMPLAINT IS BEING CLOSED WITHOUT CONCLUSION. HOWEVER, IF THE PRODUCT IS RETURNED IN THE FUTURE THE COMPLAINT CAN BE REOPENED AND EVALUATED. OUR QUALITY DEPARTMENT WILL CONTINUE TO MONITOR FOR TRENDS. NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PERINEAL BRUISING FOLLOWING A HIP ARTHROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747517 PERINEAL PAD SUPINE COMPONENT, TRACTION, NON-INVASIVE KQZ SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1