BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE

    MDR report key: 4608842 · Received March 17, 2015

    Report

    Report Number
    2210968-2015-03058
    Event Type
    Injury
    Date Received
    March 17, 2015
    Report Date
    February 23, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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 PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE ARM. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED A WOUND DEHISCENCE. THE PATIENT IS BEING SEEN BY A DERMATOLOGIST WHO OPINES THE PATIENT MAY BE HAVING AN ALLERGIC REACTION. THE PATIENT IS RECEIVING UNKNOWN TREATMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179799 VICRYL POLYGLACTIN 910 SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention