BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE

    MDR report key: 4895655 · Received July 7, 2015

    Report

    Report Number
    2210968-2015-07951
    Event Type
    Injury
    Date Received
    July 7, 2015
    Report Date
    June 12, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: CONTACT OFFICE: (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 BY THE PATIENT THAT HE UNDERWENT A MICRODISCECTOMY L3-L4 ON AN UNKNOWN DATE AND SUTURE WAS USED TO CLOSE THE INCISIONS. FIVE DAYS POST-OPERATIVELY, HE DEVELOPED A FOOD ALLERGY RESULTING IN HIVES ON HIS ARMS, BACK, AND BACK OF THE LEGS. APPROXIMATELY ONE WEEK LATER, HE WAS HOSPITALIZED FOR ANGIOEDEMA OF THE LIPS. HE HAS BEEN UNDER THE TREATMENT OF AN ALLERGIST, WHO HAS IDENTIFIED NUMEROUS FOOD ALLERGIES SINCE THE TIME OF SURGERY, AND WHO OPINED THAT THE TRICLOSAN IN THE ANTIBACTERIAL SUTURES MAY HAVE PRECIPITATED THE FOOD ALLERGIES. THE PATIENT CONTINUES TO HAVE ITCHING ON HIS LIPS AND IS TAKING MULTIPLE ANTIHISTAMINES. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440413 VICRYL PLUS POLYGLACTIN 910 SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention