BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS LL PLUS ANTIBACTERIAL SUTURE

    MDR report key: 3003940 · Received March 14, 2013

    Report

    Report Number
    2210968-2013-02464
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    NEW
    PMA / PMN Number
    K061037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: NARRATIVE - IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN ABDOMINAL SURGERY ON (B)(6) 2013 FOR A PANCREATIC TUMOR AND GIST STOMACH AND SUTURE WAS USED FOR ABDOMINAL CLOSURE. THE PATIENT EXPERIENCED A WOUND DEHISCENCE ON (B)(6) 2013. A RE-OPERATION WAS PERFORMED AT THAT TIME. THE WOUND WAS RECLOSED WITH A DIFFERENT DEVICE. THE SURGEON OPINES THAT CONTRIBUTING FACTORS FOR THE WOUND DEHISCENCE WERE OBESITY AND DIABETES. (B)(4) - WOUND DEHISCENCE OCCURRED. CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR TENSILE STRENGTH AND THEY MET THE REQUIREMENTS. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED FOR ABDOMINAL CLOSURE. THE PATIENT EXPERIENCED WOUND DEHISCENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106949 PDS LL PLUS ANTIBACTERIAL SUTURE SUTURE, ABSORBABLE NEW ETHICON, INC. NA ELM635

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention