BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB UD 3/0 30 P-14

    MDR report key: 3981498 · Received July 25, 2014

    Report

    Report Number
    1219930-2014-00564
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 2, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GAM
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: NEURO. ACCORDING TO THE REPORTER: ACCORDING TO THE REPORTER: TRANSCRANIAL (B)(6) FEMALE - WOUND BREAKDOWN. DEEP SUTURES HAD LOST TENSION AND TISSUE SEPARATION EVIDENT ON EXAMINATION UNDER ANESTHETIC. PATIENT HAD TO BE RESUTURED AND IS CURRENTLY HEALING. UNANTICIPATED TISSUE LOSS - YES - WOUND EDGE DEHISCENCE REQUIRED. NO, OTHER ADVERSE EFFECTS TO THE PATIENT. NO, EXTENSION IN INCISION. NO, UNANTICIPATED BLOOD LOSS. BUT MAY REQUIRE REPEAT GENERAL ANESTHETIC TO REMOVE SUTURES. NO SAMPLE TO RETURN AND PACKAGING DISCARDED, SO LOT NUMBER NOT KNOWN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL. "WE DON'T KNOW THE LOT NUMBER, I GATHERED AS MUCH INFORMATION AS I COULD BUT AS THEY USE THIS CODE A LOT AND THE DEHISCENCE WAS 19 DAYS POST OPERATION THEY'RE ON A NEW BOX. AS THERE WERE NO INDICATIONS OF HAVING TO RECORD IT, WE JUST COULDN'T SAY WITH ANY CERTAINTY WHICH LOT NUMBER IT COULD HAVE BEEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436626 POLYSORB UD 3/0 30 P-14 POLYSORB GAM COVIDIEN, FORMERLY US SURGICAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other