BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 3122413 · Received May 21, 2013

    Report

    Report Number
    2210968-2013-05729
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-05728. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A MYOMECTOMY ON (B)(6) 2013 AND SUTURE WAS USED. THE PATIENT STATES THAT SHE IS NOW EXPERIENCING AN ALLERGIC REACTION TO THE SUTURE. SHE HAS HIVES, DIFFICULTY BREATHING, AND GENERALIZED ITCHING. SHE ALSO STATES THAT SHE WENT INTO ANAPHYLACTIC SHOCK THREE TIMES. SHE ALSO HAS EXPERIENCED A LUPUS FLARE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224511 MONOCRYL (POLIGLECAPRONE 25) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other