BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICO 7 SINGLE DRSG 15CM X 15CM

    MDR report key: 12096101 · Received June 30, 2021

    Report

    Report Number
    8043484-2021-01623
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 14, 2021
    Report Date
    July 8, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10. THE INFORMATION RECEIVED BY THE MANUFACTURER HAS BEEN RE-EVALUATED FOR MDR REPORTING AND IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. THE LOSS OF NEGATIVE PRESSURE WOUND THERAPY DUE TO AN INOPERATIVE OR 'STOPPED' PUMP WILL NOT DIRECTLY CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH AS THE PICO DRESSING CAN REVERT TO MANAGING THE WOUND AS A STANDARD MULTILAYER DRESSING. NO RISK TO PATIENT SAFETY IS ANTICIPATED. THIS EVENT IS CONSIDERED NOT REPORTABLE PURSUANT TO 21 CFR PART 803.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING NPW TREATMENT, A PICO 7 SINGLE DRSG 15CM X 15CM WAS VIBRATING WITHOUT MAKING ANY NEGATIVE PRESSURE AND STOPPED WORKING AFTER TWO DAYS. TREATMENT WAS RESUMED, AFTER SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989302 PICO 7 SINGLE DRSG 15CM X 15CM NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1