BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 2181804 · Received July 27, 2011

    Report

    Report Number
    2210968-2011-00990
    Event Type
    Injury
    Date Received
    July 27, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ETHICON
    Product Code
    GAN
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TWO RETURNED EXPLANTED KNOTTED SUTURES WERE MICROSCOPICALLY EXAMINED. IMAGES WERE TAKEN OF BOTH KNOTS AND ALL ENDS. EACH KNOT HAD TWO "EARS" WITH CUT ENDS AND TWO ENDS THAT WERE BROKEN. FOR THE "LARGER" KNOT, THE BROKEN ENDS DID NOT MATCH, INDICATING THAT EACH WAS ATTACHED TO SOME OTHER PART OF THE SUTURE THAT WAS USED IN THE SURGERY. FOR THE "SMALLER" KNOT, IT COULD NOT BE CLEARLY DETERMINED IF THE TWO BROKEN ENDS WERE A MATCH. THE CIRCUMSTANCES AND FORCE REQUIRED TO CAUSE THE BREAKAGES AND DEHISCENCE COULD NOT BE DETERMINED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED AND TESTED FOR SUTURE KNOT TENSILE STRENGTH AND THE RESULTS OBTAINED WERE ABOVE THE REQUIREMENTS. 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.

    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. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE POSSIBLE BATCH NUMBERS: PRODUCT CODE Z371T, (B)(4), MFG DATE: 09/08/2009, EXP DATE: 07/31/2014. PRODUCT CODE Z371T, (B)(4), MFG DATE: 12/13/2010, EXP DATE: 07/31/2015. PRODUCT CODE Z371T, (B)(4), MFG DATE: 03/17/2011, EXP DATE: 01/31/2016. PRODUCT CODE Z370T, (B)(4), MFG DATE: 09/14/2010, EXP DATE: 07/31/2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ESOPHAGOGASTRECTOMY ON (B)(6) 2011 AND SUTURE WAS USED. WHILE RECOVERING IN THE HOSPITAL, THE PATIENT EXPERIENCED A WOUND DEHISCENCE. THE SUTURE WAS FOUND TO BE BROKEN WELL AWAY FROM THE KNOT. THE PATIENT UNDERWENT REOPERATION ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II (POLYDIOXANONE) SUTURE SUTURE, ABSORBABLE GAN ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention