BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACE

    MDR report key: 1842348 · Received August 30, 2010

    Report

    Report Number
    2522801-2010-00026
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    July 27, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    GAL
    PMA / PMN Number
    K896554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THREE (3) BIOHAZARD SAMPLES WERE RECEIVED ON 08/06/2010, PREPARED AND FORWARDED TO THE STERILIZER. THE SAMPLES ARE DUE BACK FROM STERILIZATION ON 09/02/2010. THE SAMPLES WILL BE EVALUATED AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION. THIS EVENT WAS INITIALLY REPORTED TO ACE SURGICAL SUPPLY CO. AND THEN FORWARDED TO ANGIOTECH. ONE (1) OTHER FINISHED GOOD LOT WAS ALSO REPORTED. THE PRODUCT INFO IS AS FOLLOWS: 3-0 CHROMIC GUT, MODEL/CATALOG#: ZG-0001N, LOT#: M316380, EXPIRATION DATE: 02/28/2015, DEVICE MANUFACTURE DATE: 02/2010, 510(K): K896554. RESULTS/CONCLUSION: THE EVAL SUMMARY WILL BE INCLUDED IN THE FOLLOW-UP REPORT. HOWEVER, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO CORRESPONDING ISSUES WERE IDENTIFIED. A DEFINITIVE CONCLUSION CAN NOT BE DRAWN AT THIS TIME. ANGIOTECH REFERENCE: (B)(4), ITEM # ZG-0001N, ACE, 3-0 CHROMIC GUT, LOT M289390, M316380.

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS ESTIMATED. DR. (B)(6) PERFORMED A DENTAL PROCEDURE USING 3-0 CHROMIC GUT SUTURE. THE DOCTOR STATES THAT THE SUTURE FRAYED AND THE NEEDLE BROKE OFF INSIDE THE PT'S MOUTH DURING THE PROCEDURE. THE ENTIRE NEEDLE WAS RETRIEVED WITHOUT DIFFICULTY. HOWEVER, POTENTIAL FOR INJURY EXISTS DUE TO THE PROXIMITY OF THE SURGICAL SITE TO THE PT'S AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACE SUTURE AND NEEDLE GAL SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) ZG-0001N M289390

    Patients

    Seq Age Sex Outcome Treatment
    1 Other