BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUROLON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 8023764 · Received October 31, 2018

    Report

    Report Number
    2210968-2018-76850
    Event Type
    Injury
    Date Received
    October 31, 2018
    Report Date
    October 16, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (NUROLON SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (NUROLON SUTURE )INVOLVED? CITATION: WORLD NEUROSURG. 2017; 97: E19-757.E23. DOI: HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.10.017. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : TRAUMATIC FRONTAL EPIDURAL HEMATOMA CAUSED BY MULTIPLE ARTERIAL INJURIES IN THE ANTERIOR FOSSA" AUTHORS: J. WILLIS KIESSLING IV, DEAN A. HERTZLER II, DAVID E.M. DRUCKER, HEATHER S. SPADER CITATION: WORLD NEUROSURG. 2017; 97: E19-757.E23. DOI: HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.10.017. THIS CASE REPORT ILLUSTRATES THE NEED TO EVALUATE THE POSSIBILITY OF MULTIPLE ARTERIAL SOURCES WHEN PRESENTED WITH A FRONTAL EPIDURAL HEMATOMA (FEH) ASSOCIATED WITH FACIAL TRAUMA. AN (B)(6) BOY WAS BROUGHT TO THE EMERGENCY DEPARTMENT WITH INCREASING EMESIS AND WORSENING FRONTAL HEADACHES AFTER HAVING BEEN STRUCK IN THE FACE BY A BASEBALL OVER THE LEFT EYE AND NOSE THE NIGHT BEFORE. NON-CONTRAST COMPUTED TOMOGRAPHY SCAN SHOWED AN EPIDURAL HEMATOMA INVOLVING THE LEFT FRONTAL LOBE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR AN EMERGENT CRANIOTOMY AND EVACUATION OF THE HEMATOMA. DURING THE SURGICAL PROCEDURE, ONCE HEMOSTASIS WAS ACHIEVED, THE HEMATOMA AND CLOT WERE EVACUATED WITH SUCTION AND IRRIGATION. TWO NUROLON 4-0 TACKING SUTURES (ETHICON) WERE USED TO ATTEMPT TO OBLITERATE THE EPIDURAL SPACE FRONTALLY, ALTHOUGH IT WAS IMPOSSIBLE TO PLACE TACKING SUTURES SUB-FRONTALLY BECAUSE OF THE LIMITATIONS OF THE CRANIOTOMY. REPORTED COMPLICATION INCLUDED PERSISTENT LEFT FRONTAL HEMATOMA WITH UNCHANGED SUBFALCINE HERNIATION IN WHICH THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR A CRANIOTOMY AND EVACUATION OF HEMATOMA AND THE PATIENT TOLERATED THE PROCEDURE WELL AND AWOKE AT HIS NEUROLOGIC BASELINE. THIS CASE DESCRIBES FEH CAUSED BY 2 DISTINCT ARTERIAL SOURCES. IT DEMONSTRATES HOW CLINICIANS SHOULD BE AWARE OF AND OPEN TO THE POSSIBILITY THAT MULTIPLE SEPARATE SOURCES OF VASCULAR INJURY COULD BE CONTRIBUTING TO THE FORMATION OF A LARGE FEH WITH EVIDENCE OF FACIAL TRAUMA AS WELL AS DEFINITIVE LINEAR SKULL FRACTURE. PREOPERATIVE AND POSTOPERATIVE IMAGING IS CRUCIAL, WITH PREOPERATIVE ANGIOGRAPHY POTENTIALLY PROVIDING A MEANS FOR AVOIDING SURGERY OR DECREASING THE MORBIDITY OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865752 NUROLON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention