BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN WOUND DEV

    MDR report key: 20600327 · Received November 4, 2024

    Report

    Report Number
    1643264-2024-00578
    Event Type
    Injury
    Date Received
    November 4, 2024
    Date of Event
    October 10, 2024
    Report Date
    December 20, 2024
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION RELATED TO A PRODUCT PROBLEM WITH A SMITH+NEPHEW DEVICE. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: CORRECTED DATA: B5, D1, D2A, D2B, D3, SECTION G (CONTACT OFFICE - MANUFACTURING SITE), H6 (MEDICAL DEVICE PROBLEM CODE). THE FEI NUMBER ASSOCIATED TO THIS REPORT SHOULD BE 8043484 INSTEAD OF 1643264. THE SUBJECT DEVICE IS MANUFACTURED BY SMITH & NEPHEW MEDICAL LTD AND NOT SMITH & NEPHEW INC AS INITIALLY INDICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VAC MACHINE HAD 2 SIGNIFICANT ISSUES WHERE PATIENTS HAVE BEEN LEFT WITHOUT CARE AS THEIR MACHINES HAVE STOPPED WORKING. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. HOWEVER, PATIENTS WERE DIRECTING BACK TO THE ED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING NPWT, THE MACHINE HAD A SIGNIFICANT ISSUE WHERE THE PATIENT WAS LEFT WITHOUT CARE AS THE MACHINE HAVE STOPPED WORKING. PATIENTS WAS DIRECTED BACK TO THE EMERGENCY DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181207 UNKNOWN WOUND DEV NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown