BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELSEAL

    MDR report key: 4780707 · Received May 15, 2015

    Report

    Report Number
    9612515-2015-00011
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Date of Event
    April 10, 2015
    Report Date
    May 15, 2015
    Manufacturer
    VASCUTEK LTD.
    Product Code
    MAL
    PMA / PMN Number
    K955230
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOR A 30CM GRAFT THAT HAS BEEN LABELED AS A 15CM GRAFT, THE RISK TO PATIENT HEALTH IS NEGLIGIBLE AS THE GRAFT CAN BE CUT TO SIZE AND USED WITHOUT IMPACT ON THE PATIENT. FOR A 15 CM GRAFT LABELED AS A 30CM GRAFT THEN THE IMPACT TO PATIENT HEALTH COULD BE SERIOUS AS THE POTENTIAL EXISTS FOR THE GRAFT NOT BE SUITABLE AND PROCEDURE WOULD BE EXTENDED. IF AN ALTERNATIVE GRAFT WAS NOT AVAILABLE, THEN THIS WOULD FURTHER INCREASE THE RISK TO PATIENT. ON THE BASIS OF THIS AND REGULATORY REPORTING REQUIREMENTS, A PRODUCT RECALL WILL BE INITIATED TO RECALL REMAINING PRODUCTS IN THE FIELD.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED TO VASCUTEK AS FOLLOWS: INCORRECT GRAFT WAS IN BOX. VASCUTEK CONTACTED SITE AND WAS INFORMED THAT THE HOSPITAL WOULD NOT RETURN GRAFT. VASCUTEK INQUIRED WHAT WAS IN THE BOX IF NOT CORRECT GRAFT. VASCUTEK WAS INFORMED THAT GRAFT IN BOX WAS TOO SHORT. VASCUTEK THEN RETRIEVED A GRAFT FROM SAME BATCH FROM WAREHOUSE STOCK. ON RECEIPT OF GRAFT THE PACKAGE WAS OPENED AND FOUND TO CONTAIN A 15CM GRAFT RATHER THAN THE 30CM INDICATED ON THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319813 GELSEAL GELSEAL STRAIGHT MAL VASCUTEK LTD. GELSEAL 301509/02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other