BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLITE MESH

    MDR report key: 3210360 · Received July 2, 2013

    Report

    Report Number
    1219977-2013-00084
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K930669
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PROLITE MESH IS THE CORRECT DESCRIPTION FOR THE REPORTED PRODUCT CODE. LOT NUMBER: PT DID NOT PROVIDE A VALID LOT NUMBER. NO DEVICE EVAL WAS PERFORMED SINCE THE DEVICE WAS NOT RETURNED TO THE MFR AND NO VALID LOT NUMBER WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED DUE TO THE FACT THAT A DEVICE MODEL NUMBER OR LOT NUMBER WAS NOT PROVIDED. ATRIUM MEDICAL CONSULTED A CLINICIAN AND HE FELT THAT THIS EVENT WAS DUE TO DEVICE BEING USED FOR PELVIC FLOOR RECONSTRUCTION. ACCORDING TO THE ATRIUM INDICATIONS FOR USE, THE PRODUCT WAS "INTENDED FOR USE IN HERNIA REPAIR, CHEST WALL RECONSTRUCTIONS, TRAUMATIC OR SURGICAL WOUNDS AND OTHER FASCIAL SURGICAL INTERVENTION PROCEDURES REQUIRING REINFORCEMENT WITH A NON-ABSORBABLE SUPPORTIVE MATERIAL." THE MESH IS LIKELY SECONDARILY INFECTION, AND / OR ERODED, WHICH CAN DIRECTLY CAUSE THE PAIN, PROLAPSE, INFECTION AND FEVER. THE CLINICIAN STATED THAT THIS IS LIKELY AN EVENT OF OFF LABEL USAGE DURING AN OPERATION KNOWN FOR INFECTIOUS COMPLICATION.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO LINK MW5042047 TO OUR PREVIOUSLY SUBMITTED FILE. THIS SAME HOME PATIENT ALSO SUBMITTED MW5030151 PREVIOUSLY.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302506 PROLITE MESH NONE FTL ATRIUM MEDICAL CORP. NOT VALID

    Patients

    Seq Age Sex Outcome Treatment
    1