BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE

    MDR report key: 1935321 · Received December 16, 2010

    Report

    Report Number
    2210968-2010-01686
    Event Type
    Injury
    Date Received
    December 16, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAP
    PMA / PMN Number
    N11397
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ALLERGIC REACTION. CONCLUSIONS: 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 A PT UNDERWENT AN ARTERIAL BIOPSY PROCEDURE ON (B)(6) 2010, AND SUTURE WAS USED EVEN THOUGH SHE IS ALLERGIC TO SILK. THE PT WAS REOPERATED ON TO REMOVE SOME OF THE SUTURE, BUT THE SURGEON COULD NOT FIND ALL OF IT. THE PT HAD AN MRI AND THE DOCTOR WAS NOT ABLE TO FIND THE REST OF THE SUTURE. THE PT HAD A "SCOPE" OF HER NOW RED AND SORE THROAT. THE PT CONTINUES TO BE ON ANTIBIOTIC, STEROIDS, BREATHING TREATMENTS AND STOMACH MEDICATIONS DUE TO ACID REFLUX FROM THE NEW MEDICATIONS. THE PT'S FACE IS STILL SLIGHTLY SWOLLEN. THE BIOPSY RESULTS WERE NEGATIVE. THE PT IS NOW BEING TREATED BY AN EAR, NOSE AND THROAT SPECIALIST AND IS PLANNING TO SEE A PULMONOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILK SUTURE SUTURE, NON-ABSORBABLE GAP ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention