BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICO

    MDR report key: 10262129 · Received July 12, 2020

    Report

    Report Number
    8043484-2020-01919
    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 WOUND BREAKDOWN ACCORDING TO THE LITERATURE REVIEW (11 PATIENTS). THE MDR NUMBERS FOR EACH PATIENT ARE: 8043484-2020-03422, 8043484-2020-03423, 8043484-2020-03424, 8043484-2020-03425, 8043484-2020-03426, 8043484-2020-03427, 8043484-2020-03428, 8043484-2020-03429, 8043484-2020-03477, 8043484-2020-03430, 8043484-2020-03476. 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, 1 OF THESE CASES PRESENTED WOUND BREAKDOWN. 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
    726062 PICO NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R