BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 1233646 · Received November 14, 2008

    Report

    Report Number
    2210968-2008-01128
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 17, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 11/14/2008. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. STUDY REPORTS THE FOLLOWING POSSIBLE PRODUCTS. MONOCRYL (POLIGLECAPRONE 25) SUTURE. MONOCRYL (POLIGLECAPRONE 25) SUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH AN INFECTION AND SEROMA AT AN UNSPECIFIED TIME FOLLOWING A BODY LIFT PROCEDURE. IT IS ASSUMED THAT ANTIBIOTICS WERE PRESCRIBED TO ADDRESS THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED; NO ADDITIONAL INFORMATION WAS RECEIVED.

    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 PRINEO SKIN CLOSURE SYSTEM