BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS LL PLUS ANTIBACTERIAL SUTURE

    MDR report key: 2896786 · Received January 4, 2013

    Report

    Report Number
    2210968-2013-00105
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    December 12, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    NEW
    PMA / PMN Number
    K061037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NECROSIS OCCURRED. 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 INFORMATION: THE ACTUAL DEVICE PRODUCT CODE AND BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCT CODES: PDP683G - LOT UNKNOWN; PDP442H - LOT UNKNOWN; PDP497G - LOT UNKNOWN.

    Additional Manufacturer Narrative · 1

    CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EVALUATED AND THEY MET THE REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE BETWEEN (B)(6) 2012 AND CONTINUOUS SUB-CUTICULAR SUTURE WAS USED. THE PATIENT PRESENTED WITH TISSUE NECROSIS EIGHT WEEKS POST OPERATIVELY WHICH DEVELOPED INTO A SECONDARY STAPH INFECTION THAT WAS SENSITIVE TO CEPHALEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4343 PDS LL PLUS ANTIBACTERIAL SUTURE SUTURE, ABSORBABLE NEW ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention