BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUT SURGICAL SUTURE

    MDR report key: 1942543 · Received December 23, 2010

    Report

    Report Number
    2210968-2010-01745
    Event Type
    Injury
    Date Received
    December 23, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAL
    PMA / PMN Number
    N10389
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - KNOTS UNTYING POST-OPERATIVELY. CONCLUSION: 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. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A DENTAL SURGERY PROCEDURE ON AN UNK DATE AND SUTURE WAS USED. THE KNOT UNTIED ONE DAY POST OP AND NEEDED TO BE RESUTURED WITH A DIFFERENT SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUT SURGICAL SUTURE SUTURE, ABSORBABLE GAL ETHICON, INC. NA CMM558

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention