BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 2032017 · Received March 28, 2011

    Report

    Report Number
    2210968-2011-00353
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    December 28, 2010
    Report Date
    March 1, 2011
    Manufacturer
    ETHICON, INC SOMERVILLE
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/28/2011. (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2011-00352. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A FOOT SURGICAL PROCEDURE ON AN UNKNOWN DATE. ON (B)(6) 2010 THE PATIENT FIRST BEGAN EXPERIENCING SYMPTOMS. THE PATIENT WAS SENT TO ANOTHER DOCTOR BECAUSE THE PATIENT HAD URTICARIA (HIVES) AT THE SITE OF THE SUTURES. THE PATIENT WAS GIVEN ANTIHISTAMINE. THE DOCTOR OPINES THE CONTRIBUTING FACTOR TO THE EVENT IS THE DISSOLVING SUTURE. CURRENTLY, THE PATIENT HAS SOME SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC SOMERVILLE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention