BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 3851744 · Received June 5, 2014

    Report

    Report Number
    2210968-2014-07185
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    November 23, 2013
    Report Date
    May 20, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2013 AND SUTURE WAS USED. SEVEN DAYS POST OPERATIVE, THE PATIENT DEVELOPED A PUERPERAL INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329415 ETHILON NYLON SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention