BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYMEM WIC SILVER CAVITY WOUND FILLER

    MDR report key: 3955153 · Received July 17, 2014

    Report

    Report Number
    1419520-2014-00001
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    May 29, 2014
    Report Date
    July 18, 2014
    Manufacturer
    FERRIS MFG. CORP.
    Product Code
    KMF
    PMA / PMN Number
    K990906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO RECEIVED VIA OUR COMMUNICATIONS WITH THE CLINIC, LEADS US TO BELIEVE THAT THE WOUND CAVITY FILLER WAS IMPROPERLY USED BY THE PT.

    Description of Event or Problem · 1

    OUR WOUND CAVITY FILLER POLYMEM WIC WAS USED TO PACK A PT'S WOUND ON (B)(6) 2014. THE FILLER WAS COVERED BY DRAWTEX WOUND DRESSING. IT WAS REPORTED TO US ON (B)(4) 2014 THAT WHEN THE WOUND DRESSING WAS REMOVED THE SAME DAY, THE CAVITY FILLER STARTED TO COME UP WITH THE DRESSING AND WAS BROKEN INTO PIECES IN THE WOUND. THE PT REMOVED PIECES OF THE POLYMEM WIC CAVITY FILLER AND REVISITED THE CLINIC ON (B)(6) 2014. THE USE OF POLYMEM WIC CAVITY FILLER WAS SUSPENDED AT THAT TIME. A CT SCAN ON (B)(6) 2014 REVEALED ANOTHER PIECE THAT WAS THEN REMOVED. RETURNED PRODUCT WAS TESTED AND THE RESULTS PASSED ALL DESIGN AND PRODUCTION CRITERIA. FOLLOW UP COMMUNICATIONS RESULTED IN NO FURTHER PROBLEMS AND THE COMPLAINT WAS CLOSED. ON (B)(4) 2014 WE WERE INFORMED THAT THE PT HAD RETURNED TO THE CLINIC AND A EXPLORATION AND DEBRIDEMENT WITHOUT ANESTHESIA PROCEDURE WAS PERFORMED TO CLEAN OUT THE WOUND. AT THAT TIME 4 PIECES WERE REMOVED. ALTHOUGH WE ARE SUSPECTING THAT THERE WERE SOME ISSUES WITH THE PROPER USE OF THE PRODUCT, THIS FURTHER INTERVENTION HAS COMPELLED US TO FILE THIS MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420057 POLYMEM WIC SILVER CAVITY WOUND FILLER WOUND FILLER KMF FERRIS MFG. CORP. REF 1333 09412E1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other