BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 3113626 · Received May 15, 2013

    Report

    Report Number
    2210968-2013-05511
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    July 20, 2012
    Report Date
    April 24, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR TENSILE STRENGTH AND THEY MET THE REQUIREMENTS. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR TENSILE STRENGTH AND THEY MET THE REQUIREMENTS. 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 SURGICAL PROCEDURE OF THE EYE ON (B)(6) 2012 AND SUTURE WAS USED. WHILE THE SURGEON WAS CLOSING THE INCISION SITE, IT WAS DISCOVERED THAT THE TIP OF THE NEEDLE WAS MISSING. THE SURGEON LOOKING FOR THE NEEDLE TIP USING A MAGNETIC STRIP BUT COULD NOT FIND IT. A CT SCAN WAS PERFORMED TO SEE IF THE NEEDLE TIP WAS LEFT IN THE PATIENT. NO INTRA-OCULAR FOREIGN BODY WAS SEEN. IT WAS REPORTED THAT THE NEEDLE PIECE WAS LEFT INSIDE THE PATIENT'S BODY. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215505 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA CPZ247

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention