BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOT TOPICAL

    MDR report key: 4167648 · Received October 13, 2014

    Report

    Report Number
    1063481-2014-00046
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON APPLIED PERCLOT TOPICAL AND FELT THAT THE POWDER DISPENSED TOO EASILY WHICH RESULTED IN MORE POWDER THAN EXPECTED AT THE SITE. HE THEN RINSED THE POWDER AND THE RESULTING GEL CLOGGED THE SUCTION DEVICE HE WAS USING TO CLEAR THE RESIDUAL PRODUCT. DURING THE MEETING BETWEEN THE SURGEON AND CRYOLIFE REPRESENTATIVES, THE SURGEON PROVIDED FEEDBACK THAT SOME CHANGES TO THE BELLOWS OR TIP THAT COULD PROVIDE MORE CONTROL WOULD BE A POSITIVE CHANGE TO THE DEVICE. HE MADE NO MENTION OF ADVERSE EFFECTS TO THE PATIENT OR INABILITY TO PROVIDE HEMOSTASIS. MANUFACTURING RECORDS HAVE BEEN REVIEWED AND THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE. ADEQUATE PRECAUTIONS AND WARNINGS ARE PRESENT IN THE PRODUCT'S INSTRUCTIONS FOR USE.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE SURGEON APPLIED PERCLOT TOPICAL AND FELT THAT THE POWDER DISPENSED TOO EASILY WHICH RESULTED IN MORE POWDER THAN EXPECTED AT THE SITE. HE THEN RINSED THE POWDER AND THE RESULTING GEL CLOGGED THE SUCTION DEVICE HE WAS USING TO CLEAR THE RESIDUAL PRODUCT. DURING THE MEETING BETWEEN THE SURGEON AND CRYOLIFE REPRESENTATIVES, THE SURGEON PROVIDED FEEDBACK THAT SOME CHANGES TO THE BELLOWS OR TIP THAT COULD PROVIDE MORE CONTROL WOULD BE A POSITIVE CHANGE TO THE DEVICE. HE MADE NO MENTION OF ADVERSE EFFECTS TO THE PATIENT OR INABILITY TO PROVIDE HEMOSTASIS.

    Description of Event or Problem · 1

    THE SURGEON APPLIED PERCLOT TOPICAL AND FELT THAT THE POWDER DISPENSED TOO EASILY WHICH RESULTED IN MORE POWDER THAN EXPECTED AT THE SITE. HE THEN RINSED THE POWDER AND THE RESULTING GEL CLOGGED THE SUCTION DEVICE HE WAS USING TO CLEAR THE RESIDUAL PRODUCT. DURING THE MEETING BETWEEN THE SURGEON AND CRYOLIFE REPRESENTATIVES, THE SURGEON PROVIDED FEEDBACK THAT SOME CHANGES TO THE BELLOWS OR TIP THAT COULD PROVIDE MORE CONTROL WOULD BE A POSITIVE CHANGE TO THE DEVICE. HE MADE NO MENTION OF ADVERSE EFFECTS TO THE PATIENT OR INABILITY TO PROVIDE HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646552 PERCLOT TOPICAL ABSORBABLE HEMOSTATIC AGENT FRO CRYOLIFE, INC. STA0003-T MS14C11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other