BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 3896910 · Received June 26, 2014

    Report

    Report Number
    2210968-2014-08249
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 6, 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

    (B)(4). 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 AN ACHILLES TENDON REPAIR ON (B)(6) 2014 AND SUTURE WAS USED. AT AN UNSPECIFIED TIME POST-OP, PURULENT DRAINAGE WAS OBSERVED WHICH RESULTED IN DELAYED WOUND HEALING AND INFECTION. THE SUTURE WAS FOUND TO NOT HAVE BEEN COMPLETELY REABSORBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375251 VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention