BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE

    MDR report key: 1151421 · Received September 4, 2008

    Report

    Report Number
    2523835-2008-00268
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ALCON PRECISION DEVICE
    Product Code
    GAR
    PMA / PMN Number
    K930517
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED SAMPLE WAS RETURNED WITH ONE NEEDLE ATTACHED TO A 6 1/4" SUTURE. A VISUAL INSPECTION WAS PERFORMED AND THE SUTURE WAS FOUND TO BE CONFORMING. MEASUREMENTS OF THE SUTURE DIAMETER WERE WITHIN SPECIFICATION. THE COMPLAINT HISTORY WAS REVIEWED AND THERE WERE NO OTHER SIMILAR COMPLAINTS FOR THE REPORTED LOT. THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO RELATED ISSUES IN MFG FOR THIS SYSTEM DURING ASSEMBLY/TESTING. THE LOTS WERE RELEASED BASED ON ALCON'S ACCEPTANCE CRITERIA. THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. THE PRODUCT DIAMETER WAS WITHIN SPECIFICATION. THIS REPORT MAILED IN TO FDA ON: 09/04/2008.

    Description of Event or Problem · 1

    THE SURGEON INITIALLY REPORTED THAT DURING THE PROCEDURE THE SUTURE THREAD APPEARED THICKER THAN NORMAL. ADDITIONAL INFO RECEIVED FROM THE SURGEON INDICATES THAT THE THICK SUTURE LEAD TO WOUND LEAKAGE, TISSUE DISTORTION, AND A FLAT CORNEAL GRAFT. THE SURGEON ALSO REPORTED THAT ADDITIONAL SUTURES WERE REQUIRED. THE SURGEON REPORTED AT THE 4 MONTH POST-OP VISIT THE PT HEALED AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE SUTURE GAR ALCON PRECISION DEVICE 8065192101 705331M

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention