BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENASYS GO

    MDR report key: 6050377 · Received October 24, 2016

    Report

    Report Number
    3006760724-2016-00159
    Event Type
    Death
    Date Received
    October 24, 2016
    Date of Event
    November 1, 2015
    Report Date
    May 16, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    OMP
    PMA / PMN Number
    K083375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    THIS EVENT WAS DISCOVERED IN A JOURNAL ARTICLE; THE DETAILS OF WHICH ARE BELOW. JOURNAL NAME: JOURNAL OF JAPANESE SOCIETY FOR EMERGENCY MEDICINE JOURNAL TITLE: THE ENGLISH TRANSLATION IS: THE DEVELOPMENT OF NECROTIZING FASCIITIS AFTER NPWT, THE CASE OF RIGHT ILIOPSOAS MUSCLE ABSCESS AND RIGHT FEMORAL ABSCESS PUBLICATION DATE: 2016, VOL. 19 PP: 430 AUTHORS NAMES: NATSUKO SATOMI, NAOYUKI KANAI ET AL THE ORIGINAL ARTICLE IS PROVIDED IN ATTACHMENT. PLEASE NOTE THAT IT WAS THE SUMMARY OF AN ORAL SESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT USING NPWT POST OPERATIVELY WENT INTO SHOCK 36 DAYS AFTER SURGERY, WHICH WAS 7 DAYS AFTER INITIATION OF NPWT. THE PATIENT HAD REDNESS AROUND THE WOUND AND A CONFIRMED INFECTION OF THE SITE. DESPITE DRAINAGE AND DEBRIDEMENT, THE PATIENT BECAME WORSE AND DIED. THE PATIENT STILL HAD COSTAL OSTEOMYELITIS AND ILIOPSOAS MUSCLE ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704108 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW, INC. 66801496

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death