BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 3981487 · Received August 5, 2014

    Report

    Report Number
    2210968-2014-10814
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ONE EXPLANTED, UNDYED SUTURE SEGMENT WAS RETURNED FOR EVALUATION. IT SHOWED STRONG SIGNS OF DISINTEGRATION. THIS APPEARANCE IS EXPECTED AFTER THE LONG TIME OF EXPOSURE TO AIR, HUMIDITY AND IMPLANTATION. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). WOUND DEHISCENCE OCCURRED. CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO 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 OSTEOSYNTHESES OF THE ANKLE BONE ON AN UNKNOWN DATE AND SUTURE WAS USED ON SUBCUTANEOUS TISSUE. AT 41 DAYS POST PROCEDURE, A PURULENT DISCHARGE WAS OBSERVED ON ONE AREA OF THE 8 CM INCISION LOCATED ON THE INTERNAL FACE OF THE FOOT. TWO THREADS OF SUTURE, WHICH HAD NOT BEGUN TO ABSORB, WERE DISCOVERED DURING A DEBRIDEMENT OF THE WOUND WHILE THE REMAINING SUTURE HAD TOTALLY ABSORBED. THE SURGEON OPINED THAT THE PATIENT HAD EXPERIENCED WOUND DEHISCENCE, DELAYED WOUND HEALING AND AN INFECTION. A DRESSING WAS APPLIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457077 VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention