BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS F MEDIUM WITH SOFT PORT

    MDR report key: 3761225 · Received April 21, 2014

    Report

    Report Number
    3006760724-2014-00193
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    September 27, 2012
    Report Date
    April 11, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K110647
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED BY SMITH & NEPHEW AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS, INCLUDING ADVERSE EVENTS, AS PART OF CORRECTIVE AND REMEDIATION ACTIONS FOLLOWING THE ISSUANCE OF THE 483 ISSUED NOVEMBER 26, 2013 TO SMITH & NEPHEW, INC. (B)(4). SMITH & NEPHEW IS PERFORMING A TWO-YEAR RETROSPECTIVE REVIEW OF COMPLAINT FILES TO RE-ASSESS REPORTABILITY CRITERIA AND REPORTING DECISIONS MADE FOR COMPLAINTS RECORDED DURING THE TIME PERIOD UNDER REVIEW. THIS COMPLAINT HAS BEEN RE-ASSESSED IN ACCORDANCE UNDER THE PROVISIONS OF 21CFR 803.50 AND DEEMED REPORTABLE AS AN MDR. WE ARE SUBMITTING ONE (1) INITIAL, 30 DAY REPORT, MEDWATCH FDA FORM 3500A, FOR A PURPORTED DEVICE MALFUNCTION WHICH OCCURRED WHILE USING THE RENASYS F MEDIUM WITH SOFT PORT.

    Description of Event or Problem · 1

    FAILURE TO ALARM: NURSE AT BEDSIDE TO DO DRESSING CHANGE. SOFT PORT LIFTED FROM PATIENT, NOT ALARMING LEAK. PATIENT'S WOUND ¿VERY WET¿ WITH POOLING. NURSE STATED THAT THE WOUND HAD DETERIORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241221 RENASYS F MEDIUM WITH SOFT PORT PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800795 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other