BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS F/P FOAM DRESSING KIT WITH PORT

    MDR report key: 3766364 · Received April 23, 2014

    Report

    Report Number
    3006760724-2014-00292
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    October 26, 2011
    Report Date
    March 7, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K082211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 (B)(4) ISSUED (B)(4) 2013 TO SMITH & NEPHEW, INC. FEI NO: (B)(4). SMITH & NEPHEW IS PERFORMING A TWO-YEAR RETROSPECTIVE REVIEW OF COMPLAINT FILES TO RE-ASSESS REPORTABILITY CRITERIA AND REPORTING DECISIONS MADE FOR COMPLIANT'S 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/P FOAM DRESSING KIT WITH PORT.

    Description of Event or Problem · 1

    FAILURE TO ALARM: DOCTOR REPORTED THAT WOUND HAD POOLING OF FLUID UNDER THE DRESSING AND WAS NOT ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247237 RENASYS F/P FOAM DRESSING KIT WITH PORT PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800640 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other