BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 3870474 · Received June 12, 2014

    Report

    Report Number
    2210968-2014-07529
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    March 1, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPHTHALMOLOGIC SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED POST-OP SUTURE BREAKAGE THREE DAYS FOLLOWING THE PROCEDURE AND THE SUTURE HAD BECOME A THICK, GELATINOUS MASS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347786 VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK HC5GBLN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention