BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLITE MESH

    MDR report key: 3961721 · Received June 16, 2014

    Report

    Report Number
    1219977-2014-00207
    Event Type
    Injury
    Date Received
    June 16, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K930669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING LOT HISTORY AND STERILIZATION RECORDS WAS CONDUCTED. ALL IN-PROCESS SPECIFICATIONS AND RELEASE CRITERIA WERE MET. BALL BURST AND SUTURE RETENTION (COURSE AND WALE DIRECTIONS) WERE CONDUCTED ON THE LOTS OF POLYPROPYLENE MESH MATERIAL AT INCOMING AND ALL ACCEPTANCE CRITERIA WAS ALSO MET. POUCH SEAL STRENGTH TESTING WAS PERFORMED IN-PROCESS PRIOR TO RELEASE OF PRODUCT TO THE STERILIZER AND ALL DATA PASSED PER QC REVIEW.

    Additional Manufacturer Narrative · 1

    A THOROUGH INVESTIGATION WAS NOT ABLE TO BE PERFORMED AS NO PRODUCT CODE, LOT NUMBER OR SAMPLE WAS PROVIDED. A REVIEW OF COMPLAINTS WAS PERFORMED AND THERE HAVE NOT BEEN ANY SIMILAR REPORTS RELATED TO A DEVICE MALFUNCTION. THIS REPORT IS BASED UPON ALLEGATIONS MADE IN A LAWSUIT IN WHICH ATRIUM MEDICAL IS NAMED DEFENDANT. THIS REPORT SHALL NOT BE CONSIDERED AS AN ADMISSION BY ATRIUM MEDICAL THAT THE PRODUCT DESCRIBED IN THE LAWSUIT AND DESCRIBED HEREIN ARE OR WERE DEFECTIVE, OR THAT IT HAD ANY CAUSAL RELATIONSHIP TO ANY INJURIES ALLEGEDLY SUFFERED BY THE PLAINTIFF.

    Description of Event or Problem · 1

    THIS EVENT IS SEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICALS MESH PRODUCT. PLAINTIFF ALLEGES MESH IMPLANTED AND INJURIES. SINCE THIS IS A LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFO OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFO IS OBTAINED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353272 PROLITE MESH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORP. 1010306-02 10426937

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention