BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROLITE MESH, HERNIA REPAIR

    MDR report key: 2964176 · Received February 13, 2013

    Report

    Report Number
    1219977-2013-00001
    Event Type
    Other
    Date Received
    February 13, 2013
    Date of Event
    December 29, 2004
    Report Date
    January 7, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K930669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO INFORMATION WAS PROVIDED REGARDING THE ATTENDING PHYSICIAN OR THE HOSPITAL WHERE THE PROCEDURE TOOK PLACE, NO ADDITIONAL INFORMATION COULD BE OBTAINED REGARDING THE EVENT. PRODUCT COMPLAINTS FOR THIS DEVICE FAMILY HAVE BEEN REVIEWED. (B)(4). THE IFU USED AT THE TIME OF THE DESCRIBED EVENT WAS REVIEWED ALONG WITH THE CURRENT IFU. THE DEVICE IS INDICATED FOR HERNIA REPAIR AND HAS NOT BEEN TESTED FOR PELVIC ORGAN PROLAPSE. NO DEVICE FROM THE SAME LOT WAS AVAILABLE FOR EVAL. WITH THE LIMITED DETAILS AND THE VERY LOW RATE OF OCCURRENCE, NO ACTION WILL BE TAKEN AT THIS TIME. COMPLAINTS ARE MONITORED AND TRENDED AND ANY INCREASE IN SIMILAR REPORTS WILL BE ASSESSED FOR POSSIBLE ACTION.

    Description of Event or Problem · 1

    PT REPORTED INTRACTABLE PERMANENT PAIN AND PROGRESSIVE DISABILITIES AFTER SACRAL COLPOPEXY MESH IMPLANT TO REPAIR PELVIC ORGAN PROLAPSE. IMPLANT DATE: (B)(6) 2004. NO PT NAME, ADDRESS, PHYSICIAN, OR HOSPITAL WAS PROVIDED. ABLE TO DETERMINE THE PRODUCT CODE FROM THE LOT # PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63380 PROLITE MESH, HERNIA REPAIR FTL ATRIUM MEDICAL CORP. 1000306-00 10008463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other