BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS LL PLUS ANTIBACTERIAL SUTURE

    MDR report key: 2992218 · Received March 7, 2013

    Report

    Report Number
    2210968-2013-02073
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    NEW
    PMA / PMN Number
    K061037
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TWO EMPTY LABELED TRAYS WERE RECEIVED FOR EVALUATION. THE EMPTY TRAYS WERE EXAMINED FOR VISUAL INSPECTION ATTRIBUTE DEFECTS UNDER 10X MAGNIFICATION AND NO DEFECTS WERE OBSERVED. THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR EVALUATION. 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 CARDIAC SURGERY ON (B)(6) 2013 AND SUTURE WAS USED. WHILE KNOTTING THE SUTURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96761 PDS LL PLUS ANTIBACTERIAL SUTURE SUTURE, ABSORBABLE NEW ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1