BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 1830544 · Received September 3, 2010

    Report

    Report Number
    2210968-2010-01032
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 6, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    NEW
    PMA / PMN Number
    N18330
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A PANCREATODUODENECTOMY PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT THE SWAGE WHEN THE SURGEON REMOVED THE NEEDLE FROM THE PACKAGE USING A NEEDLE-HOLDER. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK