BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SUTURE PRODUCT

    MDR report key: 1033810 · Received April 24, 2008

    Report

    Report Number
    2210968-2008-00279
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    December 10, 2007
    Report Date
    March 28, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - CUSTOMER REPORTS NO CAUSAL RELATIONSHIP OF THE EVENT TO THE DEVICE. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. CUSTOMER REPORTS THE FOLLOWING POSSIBLE PRODUCTS: MONOCRYL (POLIGLECAPRONE 25) SUTURE. COATED VICRYL (POLYGLACTIN 910) SUTURE. PDS II (POLYDIOXANONE) SUTURE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT PRESENTED WITH A SURGICAL WOUND DEHISCENCE APPROXIMATELY SIX WEEKS FOLLOWING AN ANTERIOR SPINAL FUSION WITH REMOVAL OF PREVIOUSLY IMPLANTED INSTRUMENTATION. THE PATIENT WAS RETURNED TO SURGERY FOR REPAIR WITH PRIMARY CLOSURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SPINAL INSTRUMENTATION - UNSPECIFIED