BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED* MULTI-LAYER LAMINATE MESH

    MDR report key: 4092616 · Received September 16, 2014

    Report

    Report Number
    2210968-2014-12850
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED CONCURRENTLY WITH HYSTERECTOMY, BSO, EXCISION OF PELVIC MASS AND LYSIS OF SMALL BOWEL ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF ABDOMINAL WALL MESH ON (B)(6) 2010 CONCURRENTLY WITH DEBRIDEMENT OF SUBCUTANEOUS FAT, AND PLACEMENT OF A WOUND VAC DUE TO MESH INFECTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT A PATIENT UNDERWENT A HERNIA REPAIR SURGERY ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSPECIFIED COMPLICATIONS, REQUIRING ADDITIONAL MEDICAL TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571050 PROCEED* MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK BAG025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention