BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 2894134 · Received January 3, 2013

    Report

    Report Number
    2210968-2013-00071
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 13, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    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 BASAL CELL REMOVAL ON THE LEFT ARM AND SUTURE WAS USED. THE INCISION BECAME PAINFUL AND RED. THERE WAS NO APPARENT INFECTION OR DRAINAGE. THE PATIENT WAS PUT ON ANTIBIOTICS AND THE SUTURE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3508 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention