BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRURASOFT PATCH

    MDR report key: 2252826 · Received September 12, 2011

    Report

    Report Number
    1213643-2011-00426
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 18, 2009
    Report Date
    August 16, 2011
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K022350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED TO DAVOL THAT A PATIENT UNDERWENT HIATIAL HERNIA REPAIR WITH A CRURASOFT PATCH IN 2009. THE PATIENT WAS ALLEGED TO HAVE DEVELOPED DYSPHAGIA FOR SIX MONTHS AFTER THE SURGERY. ADDITIONAL SURGICAL INTERVENTION WAS PERFORMED AND THE PATIENT IS REPORTED TO BE DOING WELL NOW. BASED ON THE INFORMATION PROVIDED, WE ARE UNABLE TO DETERMINE IF THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. NO SPECIFIC DEVICE FAILURE HAS BEEN REPORTED AND THERE IS NO INDICATION THAT THE PATCH WAS EXPLANTED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE, IF IT WAS EXPLANTED, FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE.

    Description of Event or Problem · 1

    BASED ON INFORMATION REPORTED TO DAVOL: ON (B)(6) 2009 - THE PATIENT UNDERWENT LAPAROSCOPIC HIATAL HERNIA REPAIR USING AN INLAY TECHNIQUE WITH A CRURASOFT PATCH. THE PATIENT HAD DYSPHAGIA FOR 6 MONTHS POST OP AND AN ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS REPORTED TO BE DOING OK NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRURASOFT PATCH FTL DAVOL INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention