BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICO 7 15CM X 15CM

    MDR report key: 12050057 · Received June 23, 2021

    Report

    Report Number
    8043484-2021-01550
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    June 9, 2021
    Report Date
    October 25, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED. 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 15X15CM CTN1 STOPPED WORKING ON THE 4TH DAY, THIS WAS NOT SOLVED AFTER BATTERIES WHERE EXCHANGED. TREATMENT WAS RESUMED (UNKNOWN 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
    946389 PICO 7 15CM X 15CM NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1