BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SUTURE PRODUCT

    MDR report key: 3041437 · Received April 8, 2013

    Report

    Report Number
    2210968-2013-03617
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - UNSPECIFIED COMPLICATIONS. HOSPITALIZATION FOR UNSPECIFIED COMPLICATIONS. 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 THE PATIENT UNDERWENT BREAST AUGMENTATION SURGERY IN (B)(6) 2011 AND SUTURE WAS USED. POST OPERATIVELY, THE PATIENT REQUIRED TWO HOSPITALIZATIONS FOR UNSPECIFIED COMPLICATIONS. THE PATIENT REQUIRES ANOTHER AUGMENTATION. NO ADDITIONAL INFORMATION WAS PROVIDED AT HIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143698 UNKNOWN SUTURE PRODUCT SUTURE GAN ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R