BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICO

    MDR report key: 10262117 · Received July 12, 2020

    Report

    Report Number
    8043484-2020-01918
    Event Type
    Injury
    Date Received
    July 12, 2020
    Date of Event
    January 1, 2018
    Report Date
    December 1, 2020
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10. FURTHER REVIEW OF THIS CASE INDICATES THIS IS A DUPLICATE REPORT. WE HAVE SUBMITTED INDIVIDUAL REPORTS FOR EACH PATIENT WHO SUFFERED A MAJOR COMPLICATION ACCORDING TO THE LITERATURE REVIEW (5 PATIENTS). THE MDR NUMBERS FOR EACH PATIENT ARE: 8043484-2020-03456, 8043484-2020-03457, 8043484-2020-03458, 8043484-2020-03459, 8043484-2020-03460. WE RESPECTFULLY REQUEST TO CLOSE THIS CASE AS A DUPLICATE AND REFER TO THE REFERENCED CASES ABOVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN A CLINICAL OBSERVATION OF "NEGATIVE PRESSURE WOUND THERAPY REDUCES WOUND BREAKDOWN AND IMPLANT LOSS IN PREPECTORAL BREAST RECONSTRUCTION" ,THAT THE PICO NEGATIVE PRESSURE WOUND THERAPY (SMITH & NEPHEW) WAS APPLIED IN 126 CASES, 5 OF THESE CASES PRESENTED MAJOR COMPLICATION (CHANGE IN MANAGEMENT SUCH AS THE PRESCRIPTION OF ANTIBIOTICS, CHANGE IN DRESSINGS, OR PROLONGED WOUND HEALINGS). IT IS UNKNOWN TREATMENT OF THIS COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726041 PICO NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R