BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENASYS GO NPWT DEVICE

    MDR report key: 12097341 · Received June 30, 2021

    Report

    Report Number
    8043484-2021-01628
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 17, 2021
    Report Date
    August 11, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    UDI-DI
    05000223464790
    PMA / PMN Number
    K083375
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. ALL PROVIDED INFORMATION HAS BEEN REVIEWED AND WE HAVE NOT BEEN ABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT OR DETERMINE A ROOT CAUSE. POTENTIAL ROOT CAUSES INCLUDE, MECHANICAL OR AN ELECTRONIC COMPONENT FAILURE. THE MANUFACTURING RECORDS SHOW NO EVIDENCE THAT THE PRODUCT DID NOT MEET THE SPECIFICATION AT THE TIME OF MANUFACTURE. A COMPLAINT HISTORY REVIEW FOUND FURTHER INSTANCES OF THE REPORTED EVENT. THE IFU HAS BEEN REVIEWED AND CONTAINS COMPREHENSIVE INSTRUCTIONS ON THE SAFE OPERATION AND USE OF THE DEVICE. THE ASSOCIATED RISK FILES CONTAIN DETAILS RELATING TO HARM. HOWEVER, AS NO HARM HAS BEEN ALLEGED THEN ADDITIONAL REVIEW IS NOT REQUIRED. THIS INVESTIGATION IS NOW COMPLETE WITH NO FURTHER ACTION DEEMED NECESSARY. SMITH + NEPHEW WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A NPW TREATMENT A RENASYS GO FAILED, THE CONSUMABLES RENASYS F MEDIUM W/SOFT PORT AND RENASYS GO CANISTER 300ML WERE CHANGED BUT PROBLEM WAS NOT SOLVED AND IT WAS NEEDED TO GO BACK TO THE SIMPLE DRESSING, WITHOUT THE RENASYS GO. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987216 RENASYS GO NPWT DEVICE NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. 05000223464790

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RENASYS F MEDIUM W/SOFT PORT, LOT 2020070908| RENASYS GO CANISTER 300M, LOT D2013403