BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 1133193 · Received August 21, 2008

    Report

    Report Number
    2210968-2008-00715
    Event Type
    Injury
    Date Received
    August 21, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    K964072
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WOUND DEHISCENCE OCCURRED, NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENT 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE PATIENT PRESENTED WITH A WOUND DEHISCENCE APPROXIMATELY TWO WEEKS FOLLOWING NECK SURGERY. PATIENT WAS RETURNED FOR RESUTURE.

    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