BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKN RENASYS

    MDR report key: 11490650 · Received March 16, 2021

    Report

    Report Number
    8043484-2021-00582
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 23, 2021
    Report Date
    March 22, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10. THE INFORMATION RECEIVED BY THE MANUFACTURER HAS BEEN RE-EVALUATED FOR MDR REPORTING AND IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. INITIALLY, 5 DEVICES WERE REPORTED AS USED, BUT ADDITIONAL INFORMATION RECEIVED CONFIRMS ONLY 2 DEVICES WERE USED. THOSE TWO DEVICES HAVE BEEN REPORTED UNDER MDR NUMBERS 8043484-2021-00580 & 8043484-2021-00581. ALL FURTHER COMMUNICATION FOR THESE EVENTS WILL BE MANAGED IN THOSE CASES, INCLUDING A FOLLOW UP REPORT WITH THE RESULTS OF OUR INVESTIGATION. WE RESPECTFULLY REQUEST TO CLOSE THE CASE AND REFER TO THE REFERENCED CASE ABOVE.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, CHANNEL OF THE RENASYS CHANNEL DRAIN DEVICE IS BLOCKED. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387860 UNKN RENASYS NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1