BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SUTURE PRODUCT

    MDR report key: 1914987 · Received November 30, 2010

    Report

    Report Number
    2210968-2010-01618
    Event Type
    Injury
    Date Received
    November 30, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2009 AND SUTURES WERE UTILIZED. THE SUTURES CAUSED THE PT "INJURY" AS THEY ARE CONTINUING TO "SPLIT OUT OF HER SKIN." NO ADDITIONAL INFO WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SUTURE PRODUCT SUTURE GAW ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention