BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMEND

    MDR report key: 2213045 · Received August 9, 2011

    Report

    Report Number
    1213643-2011-00368
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 14, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTM
    PMA / PMN Number
    K052322
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO REPORTED TO DAVOL, A COLLAMEND GRAFT WAS IMPLANTED IN THE PT. IT WAS REPORTED THAT SIX WEEKS LATER, THE PT PRESENTED WITH WOUND DEHISCENCE AND EXPOSED MESH. IT WAS NOTED THAT THERE WAS NO EVIDENCE OF TISSUE INGROWTH. THERE WAS NOTED TO BE CHRONIC GRANULATION TISSUE WITH SOME PUS, BUT NO CELLULITIS OR ODOR. THERE WAS REPORTED TO BE A HOLE IN THE CENTER OF THE GRAFT. THE MIDDLE SECTION WAS EXCISED AND A DRAIN WAS PLACED. ALTHOUGH, IT IS NOT CONFIRMED THAT INFECTION WAS PRESENT, THE IFU STATES THAT IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO MEDICAL RECORDS HAVE BEEN PROVIDED AND NO PRODUCT HAS BEEN RETURNED. WITHOUT ADD'L INFO, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BASED ON INFO REPORTED TO DAVOL: COLLAMEND MESH IMPLANTED. ON (B)(6) 2011 - SIX WEEKS POST OP, PT PRESENTED WITH DEHISCED WOUND, EXPOSED MESH. THERE WAS CHRONIC GRANULATION TISSUE AROUND WITH SOME PUS, BUT NOT REALLY BAD INFECTION, CELLULITIS OR ODOR. HOLE CENTRALLY IN GRAFT, BUT NO PROBLEMS UNDER IT. EXCISED CENTRAL PART OF MESH AND TRIED TO CLOSE WITH DRAIN PLACED. IRRIGATED WITH CHLORHEX. SMALL DRAIN HOLE LEFT AT UMBILICUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMEND FTM DAVOL INC NA DAUE0017

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention INVESTIGATIONS.| PT HAS BEEN REFERRED FOR FURTHER IMMUNOLOGICAL