BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS LL PLUS ANTIBACTERIAL SUTURE

    MDR report key: 2821235 · Received November 6, 2012

    Report

    Report Number
    2210968-2012-07044
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 9, 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). INFECTION 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 BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: PDP683G - LOT DK2267. PDP442H - LOT EE2039. PDP497G - ED2603.

    Additional Manufacturer Narrative · 1

    (B)(4) - IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT DEVELOPED AN INFECTION AND WOUND DEHISCENCE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE WOUND WAS DEBRIDED AND RECLOSED. THE SURGEON OPINES THAT THE PATIENT DEVELOPED TISSUE NECROSIS AT THE SUBCUTANEOUS LAYER WHICH DEVELOPED INTO A SECONDARY (B)(6) INFECTION.

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA. 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 ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT DEVELOPED AN INFECTION AND WOUND DEHISCENCE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE WOUND WAS DEBRIDED AND RECLOSED. THE WOUND WAS POSITIVE FOR A STAPH INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention