BEUDAMED
    FDA Adverse Event Other Summary report: N

    LOOK

    MDR report key: 1912897 · Received November 11, 2010

    Report

    Report Number
    2522801-2010-00035
    Event Type
    Other
    Date Received
    November 11, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 11, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    GAL
    PMA / PMN Number
    K896554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO ANGIOTECH FOR EVALUATION ON (B)(4) 2010 AND FORWARDED TO THE STERILIZER. UPON RETURN, THE PACKAGE WILL BE REVIEWED AND THE SAMPLE WILL BE FORWARDED TO AN OFF SITE LABORATORY TO BE ANALYZED TO CONFIRM ATTRIBUTES OF FOREIGN MATTER. THE DEVICE WAS NOT USED ON A PT. HOWEVER, THE POTENTIAL FOR INJURY EXISTS IF NON STERILE PRODUCT IS USED. METHOD: THE ACTUAL DEVICE WAS RETURNED TO ANGIOTECH FOR EVALUATION AND FORWARDED TO THE STERILIZER ON (B)(4) 2010. RESULTS/CONCLUSIONS: RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS/STERILITY RECORD FOR THE REPORTED LOT WAS REVIEWED. THERE WERE NO QUALITY ISSUES NOTED DURING THE MANUFACTURING PROCESSES OR AT FINAL RELEASE AND ALL STERILITY REQUIREMENTS WERE MET. NO OTHER COMPLAINTS WERE RECEIVED FOR THIS SPECIFIC FINISHED GOOD LOT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ADDITIONAL INFO OBTAINED FROM THE REVIEW AND ANALYSIS. (B)(4), ITEM # 525B, LOOK, 3-0 CHROMIC GUT/C6 NEEDLE, LOT M100230.

    Description of Event or Problem · 1

    REPORTED THAT UPON OPENING A PACKAGE OF CHROMIC GUT SUTURE, FOREIGN MATTER WAS OBSERVED INSIDE THE FOIL POUCH AND STAINED THE WRAPPING CARD. A PINHOLE WAS ALSO PRESENT THROUGH THE OUTER AND INNER PACKAGING WHICH COMPROMISED THE STERILITY OF THIS DEVICE. THIS SUTURE WAS NOT USED ON A PT . HOWEVER, THE POTENTIAL FOR INJURY EXISTS IF NON STERILE PRODUCT IS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOOK SUTURE AND NEEDLE GAL SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) 525B M100230

    Patients

    Seq Age Sex Outcome Treatment
    1