BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS LL PLUS ANTIBACTERIAL SUTURE

    MDR report key: 3031494 · Received April 2, 2013

    Report

    Report Number
    2210968-2013-03341
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    NEW
    PMA / PMN Number
    K061037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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 A PACEMAKER REVISION PROCEDURE ON (B)(6) 2012 AND SUTURE WAS USED. ON (B)(6) 2013, THE PATIENT PRESENTED WITH SUTURE STILL PRESENT IN INCISION AND WITH AN INFECTION AT THE SURGICAL SITE. THE PATIENT WAS PLACED ON ANTIBIOTICS AND THE VISIBLE SUTURE WAS REMOVED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135227 PDS LL PLUS ANTIBACTERIAL SUTURE SUTURE, ABSORBABLE NEW ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention