BEUDAMED
    FDA Adverse Event Summary report: N

    IV3000 1 HAND 6X7CM

    MDR report key: 3772048 · Received April 25, 2014

    Report

    Report Number
    8043484-2014-00001
    Date Received
    April 25, 2014
    Date of Event
    March 6, 2012
    Report Date
    April 24, 2014
    Manufacturer
    SMITH AND NEPHEW MEDICAL LIMITED
    Product Code
    KGX
    PMA / PMN Number
    K895353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED BY SMITH & NEPHEW AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS, INCLUDING ADVERSE EVENTS, AS PART OF CORRECTIVE AND REMEDIATION ACTIONS FOLLOWING THE ISSUANCE OF THE 483 ISSUED NOVEMBER 26, 2013 TO SMITH & NEPHEW, INC. FEI NO: (B)(4). SMITH & NEPHEW IS PERFORMING A TWO-YEAR RETROSPECTIVE REVIEW OF COMPLAINT FILES TO RE-ASSESS REPORTABILITY CRITERIA AND REPORTING DECISIONS MADE FOR COMPLAINTS RECORDED DURING THE TIME PERIOD UNDER REVIEW. THIS COMPLAINT HAS BEEN RE-ASSESSED IN ACCORDANCE UNDER THE PROVISIONS OF 21CFR 803.50 AND DEEMED REPORTABLE AS AN MDR. WE ARE SUBMITTING ONE (1) INITIAL, 30 DAY REPORT, MEDWATCH FDA FORM 3500A, FOR A PURPORTED DEVICE MALFUNCTION WHICH OCCURRED WHILE USING THE IV3000 1 HAND 6X7CM.

    Description of Event or Problem · 1

    LOW ADHESION WHEN USING THE IV 3000 NOTICED AFTER USING 8-9 DRESSINGS THAT THEY WOULD NOT PEEL/ NOT STICKING. NOTICED A COUPLE OF TIMES INSULIN WAS NOT DELIVERED PROPERLY AS A RESULT OF IT NOT STICKING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251498 IV3000 1 HAND 6X7CM TAPE AND BANDAGE, ADHESIVE KGX SMITH AND NEPHEW MEDICAL LIMITED 4007 1105

    Patients

    Seq Age Sex Outcome Treatment
    1