BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS TOUCH 300ML CNST NOSLD

    MDR report key: 10246754 · Received July 8, 2020

    Report

    Report Number
    8043484-2020-01769
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 17, 2020
    Report Date
    October 7, 2020
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    UDI-DI
    04582111155122
    PMA / PMN Number
    K153209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CASE REPORTED ON 8043484-2020-01769 WAS FOUND TO BE A DUPLICATE OF THE EVENT REPORTED IN 8043484-2020-01767, THEREFORE THE COMPLAINT REPORTED IN 8043484-2020-01769 WILL BE CLOSED. THE CURRENT INVESTIGATION WILL BE DISCARDED. THE CORRECT INVESTIGATION AND FINDINGS WILL BE REPORTED IN THE SUPPLEMENTAL REPORT FOR 8043484-2020-01767.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DEVICE WAS PLACED ON A PATIENT, THE FULL CANISTER ALARM WAS TRIGGERED. THE SAME PROBLEM OCCURRED WITH ANOTHER CANISTER FROM A DIFFERENT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710521 RENASYS TOUCH 300ML CNST NOSLD NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. 28897550 04582111155122

    Patients

    Seq Age Sex Outcome Treatment
    1