BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C0600, UNIVERSAL SEAL, (PETALS) 20/BX

    MDR report key: 5823464 · Received July 26, 2016

    Report

    Report Number
    2027111-2016-00539
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    June 2, 2016
    Report Date
    June 27, 2016
    Manufacturer
    AMR
    Product Code
    GCJ
    UDI-DI
    00607915114831
    PMA / PMN Number
    K932995
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR CANNOT ACCEPT CONTAMINATED PRODUCT FROM CUSTOMER. THE INCIDENT PRODUCT WAS NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. DURING THE MANUFACTURING PROCESS, ALL SEALS ARE THOROUGHLY INSPECTED FOR FUNCTIONALITY AND PERFORMANCE PRIOR TO PACKAGING. ALTHOUGH THE ROOT CAUSE OF THE EXPERIENCE COULD NOT BE DETERMINED, APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION AND EASE OF USE OF ITS PRODUCTS AND WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: UNKNOWN - "INSTRUMENT CATCHING INSIDE OF SEAL. NO ADVERSE EVENT/PATIENT HARM REPORTED. EVENT SAMPLE AVAILABLE BUT IS CONTAMINATED. PLEASE ADVISE IF THE SAMPLE CAN BE SHIPPED DIRECT FROM CUSTOMER ((B)(6)) TO APPLIED MEDICAL. (B)(4). CANNOT ACCEPT CONTAMINATED PRODUCT." TYPE OF INTERVENTION: "N/A." PATIENT STATUS: "NO ADVERSE/PATIENT HARM REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476803 C0600, UNIVERSAL SEAL, (PETALS) 20/BX GCJ GCJ AMR C0600 1252035 00607915114831

    Patients

    Seq Age Sex Outcome Treatment
    1