BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 3021082 · Received March 13, 2013

    Report

    Report Number
    1213643-2013-00092
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 12, 2013
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, NO DEFINITIVE CONCLUSION CAN BE DRAWN. THE PATIENT EXPERIENCED PAIN FOLLOWING THE IMPLANT AND IS CURRENTLY BEING REFERRED TO A PAIN CLINIC. PRODUCT IDENTIFIERS HAVE NOT BEEN PROVIDED, THEREFORE A MANUFACTURING REVIEW IS NOT POSSIBLE. ADDITIONALLY, THE MESH REMAINS IMPLANTED AT THIS TIME. WITH THE LIMITED INFORMATION, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY A MD: IT WAS ALLEGED THAT IN (B)(6) 2012 THE PATIENT WAS IMPLANTED WITH THE VENTRALEX HERNIA PATCH. FOLLOWING IMPLANT THE PATIENT COMPLAINED OF PAIN. THE MD ORDERED A CT SCAN, THE SCAN SHOWED NO RECURRENCE OF THE HERNIA. THE PATIENTS ABDOMEN IS NOT RED OR INFLAMED. THE PATIENT IS BEING REFERRED TO THE PAIN CLINIC AT THIS TIME FOR TREATMENT. THE SURGEON HAS CONSIDERED EXPLANTING THE DEVICE, BUT HAS TAKEN NO ACTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106492 MESH - VENTRALEX FTL DAVOL INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PAIN CLINIC