BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN PICO

    MDR report key: 10769066 · Received November 2, 2020

    Report

    Report Number
    8043484-2020-03412
    Event Type
    Injury
    Date Received
    November 2, 2020
    Date of Event
    January 1, 1901
    Report Date
    January 25, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10. H3, H6: WE HAVE NOW CONCLUDED OUR INVESTIGATION FOR THE COMPLAINT RECEIVED. A REVIEW OF THE BATCH MANUFACTURING RECORDS COULD NOT BE PERFORMED AS NO PART OR LOT NUMBERS WERE PROVIDED, HOWEVER, THERE ARE NO INDICATIONS TO SUGGEST THAT THE DEVICE DID NOT MEET SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. THE COMPLAINT HISTORY REVIEW FOUND FURTHER INSTANCES OF THE REPORTED EVENT. THE DEVICE WAS USED IN TREATMENT. AS NO SAMPLES WERE RETURNED, A PRODUCT EVALUATION COULD NOT BE CARRIED OUT. DRESSINGS SHOULD BE CHANGED AROUND EVERY 3 DAYS BUT IN SOME CASES MAY BE LEFT IN PLACE FOR 7 DAYS. IF THE ADHESIVE INTEGRITY IS COMPROMISED DUE TO PROLONGED WEAR, THE SURGICAL SITE MAY BE SUSCEPTIBLE TO EXTERNAL CONTAMINATION. A CLINICAL INVESTIGATION CONCLUDED: DURING THE STUDYING IT WAS REPORTED THAT THE PATIENT SUFFERED WOUND NECROSIS. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION CANNOT BE PERFORMED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE CANNOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. AS THE PRODUCT CODE IS UNKNOWN, A REVIEW OF THE DEVICE LABELLING COULD NOT BE CARRIED OUT. THE ASSOCIATED RISK FILE CONTAINS THE REPORTED EVENT. WE HAVE NOT BEEN ABLE TO CONFIRM A RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. NO FURTHER ACTIONS BY SMITH + NEPHEW ARE DEEMED NECESSARY AT THIS STAGE. HOWEVER, WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE. SMITH + NEPHEW ACKNOWLEDGE CUSTOMER CONCERN AND ARE CONTINUALLY INVESTIGATING WAYS TO DEVELOP AND IMPROVE OUR PRODUCTS.

    Description of Event or Problem · 1

    *LITERATURE CASE* " NEGATIVE PRESSURE WOUND THERAPY IN HIGH RISK BREAST PROCEDURES (NEGATIVE PRESSURE PICO STUDY GROUP)". AUTHORS: NAGA AMULYA MULLAPUDI, EUROPEAN JOURNAL OF SURGICAL ONCOLOGY. THE AIM OF THIS STUDY WAS TO ASSESS THE MERITS OF IMPLEMENTING A PROTOCOL FOR THE PROPHYLACTIC USE OF NPWT-PICO IN HIGH RISK BREAST PROCEDURES. THE AUTHORS OF THE STUDY REPORTED THAT ONE PATIENT SUFFERED A WOUND NECROSIS THAT WAS TREATED WITH CONSERVATIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236989 UNKN PICO NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R