BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCEED* MULTI-LAYER LAMINATE MESH

    MDR report key: 3940198 · Received July 17, 2014

    Report

    Report Number
    2210968-2014-09284
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    CONCLUSION: ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED. IT WAS NOTED THAT THERE WAS A TEAR IS IN THE FOIL POUCH.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ABDOMINAL WALL RECONSTRUCTION ON (B)(6) 2014 AND MESH WAS USED. PRIOR TO THE PROCEDURE, WHEN THE SCRUB NURSE OPENED THE FOIL TO RETRIEVE THE MESH, IT WAS NOTICED THAT THERE WAS A HOLE IN THE FOIL. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418677 PROCEED* MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK HDG073

    Patients

    Seq Age Sex Outcome Treatment
    1