BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 1672975 · Received April 29, 2010

    Report

    Report Number
    2210968-2010-00440
    Event Type
    Malfunction
    Date Received
    April 29, 2010
    Report Date
    March 29, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAK
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING 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 SURGICAL PROCEDURE ON AN UNK DATE AND SUTURE WAS USED. THE NEEDLE BROKE DURING SURGERY. THE NEEDLE FRAGMENTS WERE REMOVED DURING THE PROCEDURE WITH NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II (POLYDIOXANONE) SUTURE SUTURE, ABSORBABLE GAK ETHICON, INC. NA BLK382

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK