BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 1185943 · Received October 3, 2008

    Report

    Report Number
    2210968-2008-00952
    Event Type
    Injury
    Date Received
    October 3, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 3, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K946271
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 10/03/2008. 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT PRESENTED WITH A WOUND DEHISCENCE WITHIN A FEW WEEKS OF A TOTAL KNEE REPLACEMENT. THE PATIENT WAS RETURNED TO SURGERY FOR REPAIR.

    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 82 YR Required Intervention