BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLITE MESH

    MDR report key: 3011105 · Received March 13, 2013

    Report

    Report Number
    1219977-2013-00011
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    May 1, 2011
    Report Date
    February 15, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K930669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT REPORTED EVENT VIA FDA MEDWATCH PROGRAM. NO CONTACT INFORMATION AVAILABLE. TYPE OF SURGERY NOT STATED. WITHOUT AN UNDERSTANDING OF THE SURGICAL PROCEDURE PERFORMED OR A HOSPITAL CONTACT PERSON TO PROVIDE ADDITIONAL DETAILS REGARDING THE CASE, IT IS IMPOSSIBLE TO ASSESS POSSIBLE ROOT CAUSE. THE LOT HISTORY RECORD FOR THE DEVICE WAS REVIEWED. THE DEVICE MET PRODUCT SPECIFICATIONS AT THE TIME OF LOT RELEASE. PRODUCT COMPLAINTS WERE REVIEWED FOR THE PAST 10 YEARS AND THERE HAVE BEEN NO REPORTED PRODUCT PROBLEMS FOR THE PRODUCT CODE. (B)(4). NO DEVICE FROM THE SAME OR SIMILAR LOT WAS AVAILABLE FOR EVAL. ATRIUM CONSIDERS THIS REPORT FINAL AT THIS TIME. IF ATRIUM BECOMES AWARE OF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PT REPORTED. NO CONTACT INFORMATION AVAILABLE. TYPE OF SURGERY NOT STATED. REPORT STATES, "ANY AMOUNT OF PHYSICAL ACTIVITY LASTING MORE THAN 3 - 4 HOURS, AREA OF IMPLANT GETS TENDER AND PAINFUL. THIS SLOWS ME DOWN TREMENDOUSLY. IF I TRY TO FUNCTION AT A NORMAL PACE IT FEELS LIKE IT'S DIGGING INTO MY BODY. CERTAIN DAYS I GET SHARP PAINS AND JUST HAVE TO STOP AND SIT DOWN AND NOT MOVE FOR HOURS. REPEAT SURGERY/LAPAROSCOPY (DATE REDACTED, ASSUMING (B)(6) 2011 FROM REPORT). ACUPUNCTURE TREATMENTS 2012. STILL TAKING MEDICATION FOR PAIN, STILL SEEKING TREATMENT, CONDITION INOPERABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106712 PROLITE MESH FTL ATRIUM MEDICAL CORP. 12222204-00 10557828

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention