BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 3771190 · Received April 24, 2014

    Report

    Report Number
    2210968-2014-05253
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2014 AND SUTURE WAS USED. ON (B)(6) 2014, THE PATIENT WAS RE-SUTURED DUE TO RUPTURED STITCHES. THE PATIENT¿S CONDITION AND HEALING PROCESS ARE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250070 ETHILON NYLON SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. UNK GHB871

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention