BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 4230954 · Received November 6, 2014

    Report

    Report Number
    2210968-2014-15384
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 31, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEVERE DROP IN GENERAL CONDITION. ALL CULTURES AND BIOPSIES WERE NEGATIVE. NO PATHOLOGY OF AUTOIMMUNE OR HEMATOLOGICAL DISEASE. THE PATIENT WAS GIVEN ACQUACEL DRESSINGS AND CORTICOIDS. IN (B)(6) 2015, THE PATIENT¿S GENERAL CONDITION IMPROVED AND LAB TEST ARE NOW NORMAL. PATIENT IS GOING TO BE SCHEDULED FOR A COLONOSCOPY. DURING THE INITIAL PROCEDURE, THE PATIENT WAS GIVEN ROUTINE KEFAZOL THEN ROUTINE KEFLEX 500 FOR 7 DAYS POSTOPERATIVELY. THE PATIENT WAS NOT INFECTIOUS, BUT DID EXPERIENCE A DECREASE IN BLOOD PRESSURE AND INCREASE IN HEART RATE. THE PATIENT WAS DIAGNOSED WITH MILD SPONGIOSIS, IRREGULAR ACANTHOSIS, DERMATITIS AND DIFFUSE NEUTROPHILIC PANNICULITIS. (B)(4).

    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 A PATIENT UNDERWENT AUGMENTATION MAMMOPLASTY WITH IMPLANTS ON (B)(6) 2014 AND SUTURE WAS USED. THE FOLLOWING DAY THE PATIENT DEVELOPED A REACTION. THE PATIENT WAS DIAGNOSED WITH PYODERMA GANGRENOSUM. AROUND (B)(6) 2014, THE SURGEON REMOVED THE BREAST IMPLANTS. SHE WAS TRANSFERRED TO INTENSIVE CARE FOR OBSERVATION. IT WAS NOTED THAT THE TISSUE WAS OPENED. THE PATIENT¿S WOUND CARE WAS A VACUUM WITH DRESSING CHANGES EVERY 2 DAYS. DUE TO THE AUTO IMMUNE NATURE OF PYODERMA GANGRENOSUM AND THE LOSS OF PLATELETS SHE WAS GIVEN ALBUMIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713284 ETHILON NYLON SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| R BREAST IMPLANTS| ALLERGAN BREAST IMPLANTS