BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMED FM

    MDR report key: 2890559 · Received December 12, 2012

    Report

    Report Number
    1213643-2012-00863
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 19, 2012
    Manufacturer
    DAVOL INC.
    Product Code
    FTM
    PMA / PMN Number
    K082687
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, NO DEFINITIVE CONCLUSION CAN BE DRAWN. THE INFORMATION PROVIDED INDICATES THAT THE PATIENT WAS TREATED FOR A FISTULA AND ADHESIONS, BOTH OF WHICH ARE KNOWN ADVERSE EVENTS LISTED IN THE IFU. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED INCLUDING A REVIEW OF STERILITY RECORDS AND THERE WAS NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A COLLAMEND FM WAS PLACED ON (B)(6) 2012 FOR A HERNIA REPAIR. AFTER PLACEMENT A FISTULA ON THE SMALL INTESTINE (BOWEL) WAS NOTICED. A PARTIAL EXPLANT OF THE MESH TOOK PLACE ON (B)(6) 2012. ON (B)(6) 2012 THE MESH WAS ENTIRELY REMOVED AS A NEW FISTULA WAS NOTICED WITH LARGE ADHESION TO THE ENTIRE BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMED FM FTM DAVOL INC. NA DAWE0006

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR