BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS PLUS ANTIBACTERIAL (POLYDIOXANONE) SUTURE

    MDR report key: 4202673 · Received October 27, 2014

    Report

    Report Number
    2210968-2014-14967
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    K061037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED THE NEEDLE FAILED IN A DUCTILE MANNER. THERE ARE NO SIGNS OF MANUFACTURING DEFECTS FOUND ON THE NEEDLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED. DURING PASSAGE THROUGH THE DERMIS, THE NEEDLE BROKE AT THE MIDDLE. IT WAS UNKNOWN WHETHER THE BROKEN PIECE FELL INTO THE PATIENT¿S BODY OR NOT IN THE FIRST PLACE, HOWEVER, IT IS POSSIBLE THAT THE PIECE COULD BE RETAINED IN THE PATIENT. AN X-RAY WAS TAKEN TO SEARCH FOR THE BROKEN PIECE, BUT IT WAS NOT FOUND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683700 PDS PLUS ANTIBACTERIAL (POLYDIOXANONE) SUTURE SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other