BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 1092223 · Received August 1, 2008

    Report

    Report Number
    2210968-2008-00648
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    May 1, 2008
    Report Date
    July 14, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    K964072
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    WOUND DIHISCENCE OCCURRED - CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT PRESENTED WITH WOUND DEHISCENCE IN 2008 TWO WEEKS FOLLOWING A VEIN STRIPPING PROCEDURE. THE WOUNDS SUBSEQUENTLY BECAME INFECTED DUE TO ENVIRONMENTAL FACTORS. ANTIBIOTICS WERE PRESCRIBED. THE WOUNDS WERE ALLOWED TO HEAL BY SECONDARY INTENTION. THE PT IS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOCRYL (POLIGLECAPRONE 25) SUTURE SUTURE, ABSORBABLE GAN ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DERMABOND TOPICAL SKIN ADHESIVE