BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK SUTURE

    MDR report key: 1133523 · Received August 21, 2008

    Report

    Report Number
    2210968-2008-00719
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAP
    PMA / PMN Number
    N11397
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT A SURGICAL KNOT UNTIED WHILE THE DENTIST WAS TAKING A TOOTH IMPRESSION FOLLOWING A LIP LACERATION CLOSURE. A SECOND KNOT UNTIED THE FOLLOWING DAY. THE REMAINING SUTURE AND SURGICAL KNOTS WERE SUBSEQUENTLY EXPLANTED PER ROUTINE PROCEDURE. SUTURE USED WAS ALL FROM ONE STRAND. NO ADVERSE PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILK SUTURE SUTURE, NON-ABSORBABLE GAP ETHICON, INC. NA ZCR619

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR