BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 2063405 · Received April 19, 2011

    Report

    Report Number
    2210968-2011-00451
    Event Type
    Injury
    Date Received
    April 19, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ETHICON, INC
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE LID SURGICAL PROCEDURE ON AN UNKNOWN DATE. GRANULOMA FORMATION WAS OBSERVED BENEATH THE KNOT ON THE LOWER EYE LID APPROXIMATELY ONE WEEK POST-OPERATIVELY. THE SURGEON OPINES THAT SUTURE ABSORPTION DID NOT OCCUR DURING SCHEDULED TIME, AS IN THE PAST THE KNOTS JUST FELL OFF. THE PATIENT WAS TREATED WITH CORTISONE OINTMENT WITH NOT MUCH SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC NA CL5CDQN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention