BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENASYS TOUCH NON CONNECT 4TH ED DEVICE

    MDR report key: 22081283 · Received May 23, 2025

    Report

    Report Number
    8043484-2025-00056
    Event Type
    Death
    Date Received
    May 23, 2025
    Date of Event
    September 7, 2024
    Report Date
    August 8, 2025
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    UDI-DI
    05000223495046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS RETURNED FOR EVALUATION IN THE SERVICE CENTER. THE VISUAL AND FUNCTIONAL EVALUATION DID NOT REVEAL A PHYSICAL OR FUNCTIONAL FAILURE. THE EXACT CAUSE OF THE PATIENT'S DEATH REMAINS UNKNOWN DUE TO INSUFFICIENT INFORMATION, THOUGH POSSIBLE FACTORS INCLUDE A POST-PROCEDURAL COMPLICATION OR PRE-EXISTING MEDICAL CONDITIONS REQUIRING HOSPICE CARE. SPECIFIC DETAILS RELATED TO THE PATIENT'S ABDOMINAL WOUND WERE NOT PROVIDED; HOWEVER, THE PHYSICIAN ORDERED NEGATIVE PRESSURE WOUND THERAPY (NPWT) AND WAS PRESENT DURING ITS INITIAL APPLICATION. AS THE CLINICIAN USER MANUAL FOR THE RENASYS TOUCH, INSTRUCTS PRIOR TO PLACEMENT, "THE MEDICAL PROFESSIONAL TREATING THE WOUND MUST ASSESS HOW TO BEST USE THE SYSTEM FOR AN INDIVIDUAL WOUND. IT IS IMPORTANT TO CAREFULLY ASSESS BOTH THE WOUND AND THE PATIENT TO ENSURE THE CLINICAL INDICATIONS FOR NPWT ARE MET". THE ATTENDING PHYSICIAN STATED THAT THERE WAS NO CONNECTION BETWEEN THE RENASYS DEVICE AND THE PATIENT¿S DEATH. A DEATH CERTIFICATE HAS YET TO BE PROVIDED, LIMITING FURTHER ASSESSMENT, BUT THERE IS NO INDICATION THAT THE PATIENT¿S DEATH WAS RELATED TO THE SMITH & NEPHEW DEVICE. ANY FURTHER IMPACT ON THE PATIENT BEYOND WHAT HAS BEEN REPORTED COULD NOT BE ASSESSED. THE REVIEW OF THE DEVICE'S PRODUCTION RECORDS SHOWED NO MANUFACTURING ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. NO SIMILAR EVENTS WERE FOUND IN THE COMPLAINT HISTORY FOR THIS PART NUMBER DURING THE LAST 14 MONTHS. THERE HAVE BEEN NO PREVIOUS ESCALATED ACTIONS FOR THE PART NUMBER AND OUTCOME REPORTED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. THE REPORTED DEVICE WILL BE RETAINED BY THE MANUFACTURER.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A PHYSICIAN TREATED AN ABDOMINAL WOUND OF A HOSPICE PATIENT WITH THE DEVICE. THE PATIENT DIED IN THE DAYS AFTER THE TREATMENT. ACCORDING TO THE PHYSICIAN, A CAREGIVER WHO WAS PRESENT DURING THE TREATMENT HAS RAISED CONCERNS VIS-A-VIS THE GERMAN INVESTIGATING AUTHORITIES AS TO WHETHER THE WOUND THERAPY WAS INDICATED/PROPERLY CARRIED OUT AND THE DEVICE WAS PROPERLY FUNCTIONING. AT THIS POINT IN TIME, THE MANUFACTURER IS NOT AWARE OF ANY PROBLEM WITH THE DEVICE NOR THAT THE DEATH OCCURRED IN CONNECTION WITH THE USE OF THE DEVICE. THE NOTIFICATION IS MADE AS A PURELY PRECAUTIONARY MEASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366690 RENASYS TOUCH NON CONNECT 4TH ED DEVICE NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. 05000223495046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death 66800795| 66801273