BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

    MDR report key: 4095223 · Received September 17, 2014

    Report

    Report Number
    3006760724-2014-00408
    Event Type
    Death
    Date Received
    September 17, 2014
    Date of Event
    September 2, 2014
    Report Date
    April 16, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    OMP
    PMA / PMN Number
    K083375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS; RESULTS OF THE INVESTIGATION WILL BE SUBMITTED IN A SUPPLEMENT REPORT. THE CAUSE OF THE PATIENT DEATH WAS NOT DUE TO A RENASYS AT ALL. THE REASON FOR THE DEATH WAS DUE TO THE GENERAL CONDITION OF THE PATIENT.

    Description of Event or Problem · 1

    RENASYS WAS USED THE PATIENT WHO UNDERWENT AMPUTATION AT THE THIGH DUE TO PAD WITHOUT ANY REVASCULARIZATION. DOCTOR DIDN'T SUTURE THE AMPUTATION STUMP AND THE SYMPTOM OF INFECTION(REDDENING, HEAT SENSATION AND SWOLLEN) WAS OBSERVED. EVEN IF THE DOCTOR CONDUCTED DÉBRIDEMENT, NECROSIS AREA GOT WORSE AND DOCTOR DIDN'T CONDUCT DÉBRIDEMENT AFTER ALL. PATIENT GENERAL CONDITION WAS SERIOUS THAT IT WOULD BE IMPOSSIBLE TO LIVE BY SEPTEMBER. DOCTOR WANTED TO USE RENASYS TO THIS PATIENT FOR THE EXUDATE MANAGEMENT, THOUGH DOCTOR UNDERSTAND THIS PATIENT CONDITION WAS ELIGIBLE TO USE RENASYS. DURING THERAPY THIS PATIENT PASSED AWAY. AS DOCTOR'S REMARKS, DOCTOR BELIEVE THE CAUSE OF PATIENT DEATH WAS NOT DUE TO RENASYS AT ALL. IT IS FOR HER GENERAL CONDITION AND THE DEVICE WAS NO PROBLEM.

    Description of Event or Problem · 1

    RENASYS WAS USED THE PATIENT WHO UNDERWENT AMPUTATION AT THE THIGH DUE TO PAD WITHOUT ANY REVASCULARIZATION. DOCTOR DIDN'T SUTURE THE AMPUTATION STUMP AND THE SYMPTOM OF INFECTION (REDDENING, HEAT SENSATION AND SWOLLEN) WAS OBSERVED. EVEN IF THE DOCTOR CONDUCTED DEBRIDEMENT, NECROSIS AREA GOT WORSE AND DOCTOR DIDN'T CONDUCT DEBRIDEMENT AFTER ALL. PATIENT GENERAL CONDITION WAS SERIOUS THAT IT WOULD BE IMPOSSIBLE TO LIVE BY SEPTEMBER. DOCTOR WANTED TO USE RENASYS TO THIS PATIENT FOR THE EXUDATE MANAGEMENT, THOUGH DOCTOR UNDERSTAND THIS PATIENT CONDITION WAS ELIGIBLE TO USE RENASYS. DURING THERAPY THIS PATIENT PASSED AWAY. AS DOCTOR'S REMARKS, DOCTOR BELIEVE THE CAUSE OF PATIENT DEATH WAS NOT DUE TO RENASYS AT ALL. IT IS FOR HER GENERAL CONDITION AND THE DEVICE WAS NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574112 NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP RENASYS EZ PLUS OMP SMITH & NEPHEW, INC. WD000000000066800697 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1