BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 1233642 · Received November 14, 2008

    Report

    Report Number
    2210968-2008-01132
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    May 15, 2008
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WOUND DEHISCENCE OCCURRED. 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: LOT# ZM5DQKN, MFG: 11/29/2007, EXP: 12/31/2012. LOT: AB5GBSN, MFG: 03/03/2008, EXP: 06/30/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH A WOUND BREAKDOWN AT AN UNSPECIFIED TIME FOLLOWING BILATERAL BREAST SURGERY. UNSPECIFIED MEDICAL INTERVENTION WAS PROVIDED TO ADDRESS THE WOUND BREAKDOWN. 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 WOUND CLOSURE SYSTEM