BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (PROLIGLECAPRONE 25) SUTURE

    MDR report key: 1233650 · Received November 14, 2008

    Report

    Report Number
    2210968-2008-01124
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    September 16, 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

    INFECTION 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 DEVELOPED A LOCALIZED INFECTION FIVE DAYS FOLLOWING A ABDOMINOPLASTY PROCEDURE. A TOPICAL ANTIBIOTIC WAS PRESCRIBED. THE INFECTION REPORTEDLY RESOLVED THREE DAYS LATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention PRINEO SKIN CLOSURE SYSTEM