BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 1222105 · Received November 5, 2008

    Report

    Report Number
    2210968-2008-01092
    Event Type
    Injury
    Date Received
    November 5, 2008
    Report Date
    September 24, 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: 11/05/2008. 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 VIA E-MAIL THE RESULTS OF A SURVEY OF PEDIATRIC OPHTHALMIC AND STRABISMUS SURGEONS THAT SHOWED AN INCREASE IN THE INCIDENCE OF POST-OPERATIVE INFLAMMATION. NO SPECIFIC EVENT DETAILS WILL BE FORTHCOMING.

    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