BEUDAMED
    FDA Adverse Event Other Summary report: N

    LOOK

    MDR report key: 823103 · Received February 20, 2007

    Report

    Report Number
    2522801-2007-00001
    Event Type
    Other
    Date Received
    February 20, 2007
    Date of Event
    December 22, 2006
    Report Date
    February 19, 2007
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DOING BUSINESS AS ANGIOTECH)
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHIN THE "PRECAUTIONS" SECTION OF THE IFU FOR THIS ITEM, IT STATES "IN HANDLING THIS OR ANY OTHER SUTURE MATERIAL, CARE SHOULD BE TAKEN TO AVOID DAMAGE FROM HANDLING. AVOID CRUSHING OR CRIMPING DAMAGE DUE TO APPLICATION OF SURGICAL INSTRUMENTS SUCH AS FORCEPS OR NEEDLE HOLDERS. AS WITH ANY SUTURE MATERIAL, ADEQUATE KNOT SECURITY REQUIRES THE ACCEPTED SURGICAL TECHNIQUE OF FLAT, SQUARE TIES, WITH ADD'L THROWS AS WARRANTED BY SURGICAL CIRCUMSTANCES AND THE EXPERIENCE OF THE SURGEON. THE USE OF ADD'L THROWS MAY BE PARTICULARLY APPROPRIATE WHEN KNOTTING MONOFILAMENTS". THE DR'S ASSISTANT DID NOT PROVIDE INFO ON THE DR'S KNOT TECHNIQUE OR THE TYPE OF STITCH USED TO APPROX THE INCISION. IN 02/05/2007 - 02/06/2007, UNOPENED SAMPLES OF THE COMPLAINT PRODUCT WERE RETURNED TO ANGIOTECH FROM THE DR'S OFFICE FOR EVAL. A VISUAL EVAL, U.S.P. DIMENSION AND KNOT PULL TEST WERE PERFORMED ON TWELVE (12) PIECES. ALL SAMPLES WERE NOTED TO HAVE NO IRREGULARITIES AND THE RESULTS OF THE TESTS PERFORMED WERE ACCEPTABLE AND MET THE CURRENT U.S.P., AND ANGIOTECH SPEC REQUIREMENTS.

    Description of Event or Problem · 1

    DR'S ASSISTANT REPORTED ON 1/26/07 THE DR (INTERNAL MEDICINE/DERMATOLOGIST) WAS EXPERIENCING BREAKAGE DURING USE WITH 3/0 BLACK MONOFILAMENT NYLON SUTURE (ITEM #925B - LOT #M962220) AND ALSO REPORTED ONE (1) INCIDENT WHERE A PT THAT WAS TREATED FOR SKIN LESION REMOVAL RETURNED TWO (2) DAYS POST-OP WITH BROKEN SUTURES WHICH RESULTED IN RE-EXCISION, RE-SUTURE AND TREATMENT WITH ANTIBIOTICS. THE DR'S ASSISTANT STATED THAT THE PT HAS SINCE RECOVERED AND IS FINE EXCEPT FOR MORE THAN USUAL SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOOK SUTURE AND NEEDLE GAM SURGICAL SPECIALTIES CORP. (DOING BUSINESS AS ANGIOTECH) 925B M962220

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention