BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERISET HEMOSTATIC PATCH 2X4CM

    MDR report key: 4102561 · Received September 16, 2014

    Report

    Report Number
    3003157248-2014-00001
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 15, 2014
    Manufacturer
    COVIDIEN, FORMERLY CONFLU
    Product Code
    LMG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PATIENT HAD AN INFECTION IN THE WOUND OF THE SKIN, A COUPLE OF DAYS AFTER THE THYROIDECTOMY. HE/SHE HAD TO GOT TO THE EMERGENCY DEPARTMENT WHERE HE/SHE RECEIVED ANTIBIOTIC. THE PATIENT HAS RECOVERED WELL. THE SURGEON THOUGHT THAT THE VERISET MIGHT BE THE REASON FOR THE INFECTION. HE ALSO SAID THAT THE REASON MIGHT ALSO BE ANYTHING ELSE THAT USED IN THE OPERATION. THE SURGEON DOES NOT WANT TO USE VERISET AT THE MOMENT. PRODUCT HAS NOT BEEN RE-STERILIZED PRIOR TO THIS INCIDENT. NO EXTENSION OF SURGERY TIME BY MORE THAN 30 MINUTES, NO BLOOD LOSS OF MORE THAN 250 CC, NO EXTENSION OF THE INCISION OF MOR THAN 1 INCH, NO UNANTICIPATED OR IRREVERSIBLE DAMAGE TO VASCULAR TISSUE, NOTHING FELL INTO PATIENT CAVITY. NO REINFORCEMENT MATERIAL.

    Description of Event or Problem · 1

    SURGERY DATE: (B)(6). REASON FOR SURGERY: STRUMA. DATE INFECTION DIAGNOSED: I'M NOT SURE BUT DR. (B)(6) SAID THAT THE PATIENT GOT THE INFECTION COUPLE OF DAYS AFTER THE THYROIDECTOMY. HOW WAS THIS INFECTION DIAGNOSED? THE PATIENT HAD TO GO TO THE EMERGENCY DEPARTMENT WHERE HE/SHE GOT THE ANTIBIOTIC. I UNDERSTOOD THAT THE DOCTOR HAD SAW THAT THE WOUND OF THE SKIN WAS INFECTED. CULTURE? DR. (B)(6) DIDN'T MENTION ABOUT THAT BUT NORMALLY THEY TAKE THE CULTURE IN THIS KIND OF SITUATION. I DON'T KNOW THE COMORBIDIES OF THE PATIENT. I MET DR. (B)(6) TODAY AND HE TOLD ME MORE ABOUT THIS INFECTION CASE. THEY HAD ALSO DONE THE CULTURE AND THEY DIDN'T FIND ANY BACTERIA. HE HAD ALSO MET THE PATIENT AGAIN AND HE/SHE HAD RECOVERED WELL. DR. (B)(6) ALSO SUSPECTED THAT COULD THE REACTION BE SOME KIND OF ALLERGY. PER FURTHER INFORMATION, THIS WAS NOT AN INFECTION AND MAY BE AN ALLERGIC REACTION. WOUND CULTURE WITHOUT BACTERIA. WE HAVE THE FIRST MISC CODE AS INFECTION WHICH BASED ON THIS NEW INFORMATION IS NO LONGER APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572139 VERISET HEMOSTATIC PATCH 2X4CM VERISET HEMOSTATIC PATCH LMG COVIDIEN, FORMERLY CONFLU C061043-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other