BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL GUT SUTURE - CHROMIC

    MDR report key: 3830447 · Received May 23, 2014

    Report

    Report Number
    2210968-2014-06602
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    February 12, 2013
    Report Date
    May 2, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAL
    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 CESAREAN SECTION ON (B)(6) 2013 AND SUTURE WAS USED. ON (B)(6) 2013, THE PATIENT DEVELOPED PUERPERAL INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307189 SURGICAL GUT SUTURE - CHROMIC SUTURE, ABSORBABLE, NATURAL GAL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other