BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 1211118 · Received October 23, 2008

    Report

    Report Number
    2210968-2008-01035
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 27, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K946271
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 10/23/2008. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WIL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT DEVELOPED AN INFECTION APPROXIMATELY ONE WEEK FOLLOWING AN ORTHOPEDIC PROCEDURE. THE ORTHOPEDIC DEVICES AND THE SUTURE USED TO ANCHOR THESE DEVICES WERE REMOVED. THE PT REPORTED TO THE CUSTOMER THAT HE HAS ACNE; THE SAME BACTERIAL ORGANISM ASSOCIATED WITH THE ACNE IS THE CAUSAL ORGANISM OF THE REPORTED INFECTION. NO FURTHER INFO WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ANCHOR IMPLANTS| ABSORBABLE ANCHORS