BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS CORD

    MDR report key: 3243230 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14227
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. ONE NEEDLE WAS NOT ATTACHED TO THE SUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343325 PDS CORD SUTURES - ABSORBABLE NEW ETHICON INC. DB8HJRC0

    Patients

    Seq Age Sex Outcome Treatment
    1