BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 2072189 · Received April 28, 2011

    Report

    Report Number
    2210968-2011-00533
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 4, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ETHICON INC
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/28/2011. (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: REPRESENTATIVE SAMPLES OF THE RETURNED PRODUCT WERE TESTED FOR KNOT PULL TENSILE STRENGTH AND TEST IN VITRO. THE RESULTS OBTAINED WERE IN CONFORMANCE WITH THE REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ECTROPION EYE LID SURGICAL PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. ON (B)(6) 2011, THE PATIENT EXPERIENCED INFLAMMATION OF THE WOUND AND ABSENCE OF SUTURE ABSORPTION. THE PATIENT UNDERWENT REMOVAL OF ALL THE SUTURES AND WAS TREATED WITH STERDEX AND AUGMENTIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention