BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PICO

    MDR report key: 17877723 · Received October 5, 2023

    Report

    Report Number
    8043484-2023-00073
    Event Type
    Injury
    Date Received
    October 5, 2023
    Date of Event
    November 1, 2022
    Report Date
    January 24, 2024
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED. DOI: DOI.ORG/10.1016/J.BJPS.2022.08.006 NGUYEN, C. L., TAM, S. K. M., EASWARALINGAM, N., SEAH, J. L., COMERFORD, A. P., YU, A. C. X., ... & WARRIER, S. K. (2022). PATTERNS OF ISCHAEMIA AND REPERFUSION IN NIPPLE-SPARING MASTECTOMY RECONSTRUCTION WITH INDOCYANINE GREEN ANGIOGRAPHY. JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY, 75(11), 4144-4151.

    Additional Manufacturer Narrative · 0

    THIS CASE WAS REPORTED FOLLOWING A LITERATURE REVIEW, NO PRODUCT WAS EXPECTED TO BE RETURNED. A DOCUMENTATION REVIEW WAS PERFORMED MANUFACTURING RECORDS COULD NOT BE PERFORMED, NO PRODUCT IDENTIFIER WAS PROVIDED. COMPLAINT HISTORY RECORDS DETAILS A SMALL NUMBER OF CASES OF THIS NATURE, WITH NO OPEN OR CLOSED ESCALATIONS WITHIN THE SCOPE OF THIS REPORT. THE INSTRUCTION FOR USE "IFU" REVEALS NO CONTRIBUTORY FACTORS AND REQUIRES NO UPDATE. IN THIS CASE, THE RISK MANAGEMENT DOCUMENTATION FOR PICO COULD NOT BE REVIEWED, NO CLEAR FAILURE IS OUTLINED WITHIN THE COMPLAINT DESCRIPTION OR ASSOCIATED PAPER. A MEDICAL REVIEW CONCLUDED THAT INSUFFICIENT INFORMATION HAD BEEN PROVIDED TO IDENTIFY REASON FOR READMISSION. NO MANUFACTURING, PACKAGING, LABELLING, DESIGN, CONCERNS NOR ADVERSE TREND HAVE BEEN OBSERVED, THEREFORE NO CORRECTIVE ACTIONS ARE DEEMED NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "PATTERNS OF ISCHAEMIA AND REPERFUSION IN NIPPLE-SPARING MASTECTOMY RECONSTRUCTION WITH INDOCYANINE GREEN ANGIOGRAPHY", 10 PATIENT REQUIRED READMISSION IN THE HOSPITAL AFTER A NIPPLE-SPARING MASTECTOMY RECONSTRUCTION PROCEDURE USING A PICO DEVICE FOR WOUND MANAGEMENT. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2256830 UNKNOWN PICO NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown