BEUDAMED
    FDA Adverse Event Other Summary report: N

    PATTERSON DENTAL

    MDR report key: 1772741 · Received July 26, 2010

    Report

    Report Number
    2522801-2010-00016
    Event Type
    Other
    Date Received
    July 26, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 26, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    GAL
    PMA / PMN Number
    K896554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    STERILE SAMPLES WERE RETURNED TO ANGIOTECH FOR EVALUATION ON (B)(4) 2010. THIS INCIDENT WAS INITIALLY REPORTED TO PATTERSON DENTAL, THE DISTRIBUTOR OF THIS PRODUCT. PATTERSON DENTAL THEN NOTIFIED ANGIOTECH. BOTH OF THE NEEDLES WERE RETRIEVED. HOWEVER, POTENTIAL FOR INJURY EXISTS IF A NEEDLE ENTERS THE PATIENT'S AIRWAY. FOUR (4) OTHER PATTERSON DENTAL FINISHED GOOD LOTS WERE ALSO REPORTED. METHOD: THE ACTUAL DETACHED DEVICES WERE NOT RETURNED FOR EVALUATION. THE EXACT LOT THAT WAS USED WHEN THE NEEDLES DETACHED COULD NOT BE CONFIRMED BY THE DENTIST. HOWEVER, STERILE DEVICES FROM ALL OF THE REPORTED LOTS WERE RETURNED AND TESTED IN ANGIOTECH'S QUALITY ASSURANCE LABORATORY. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS FOR ALL OF THE REPORTED LOTS WERE REVIEWED. RESULTS/CONCLUSION: ALL TESTED SAMPLES MET USP AND ANGIOTECH REQUIREMENTS. THE ALLEGED FAILURE COULD NOT BE DUPLICATED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS FOR ALL OF THE REPORTED LOTS WERE REVIEWED. THERE WERE NO QUALITY ISSUES NOTED DURING THE MANUFACTURING PROCESSES OR AT FINAL RELEASE. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS ESTIMATED. DR (B)(6) REPORTED THAT DURING A DENTAL PROCEDURE WHERE 3-0 CHROMIC GUT SUTURE WAS USED, THE SUTURE WAS NOTED TO FRAY DURING USE. HE ALSO STATED THAT HE EXPERIENCED TWO (2) NEEDLES THAT DETACHED FROM THE SUTURE AND DROPPED INTO THE PATIENT'S MOUTH. BOTH OF THE NEEDLES WERE RETRIEVED. HOWEVER, POTENTIAL FOR INJURY EXISTS IF A NEEDLE ENTERS THE PATIENT'S AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATTERSON DENTAL SUTURE AND DENTAL GAL SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) WP-0052N M125980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention