BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 1233649 · Received November 14, 2008

    Report

    Report Number
    2210968-2008-01125
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 7, 2007
    Report Date
    October 17, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    K964072
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEHISCENCE OCCURRED. 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 REPORTED PAIN AND PRESENTED WITH A 2.5CM PARTIAL THICKNESS WOUND DEHISCENCE FIVE DAYS FOLLOWING A BODY LIFT PROCEDURE. THE INITIAL TOP LAYER OF THE INCISION OF THE RIGHT BUTTOCKS WAS CLOSED IN A RUNNING CONTINUOUS FASHION. THE PATIENT WAS RETURNED TO SURGERY FOR REPAIR ON POST-OP DAY 6. COMPLETE SITE APPROXIMATION WAS REPORTED ON POST-OP DAYS 12 AND 25.

    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 50 YR Required Intervention PRINEO SKIN CLOSURE SYSTEM