BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 7696040 · Received July 17, 2018

    Report

    Report Number
    2210968-2018-74457
    Event Type
    Death
    Date Received
    July 17, 2018
    Report Date
    June 26, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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 THE ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THAT ETHICON SUTURE CAUSED/ CONTRIBUTED TO THE NEONATAL DEATH (DUE TO HYPOXIA AND SEPSIS)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCTS USED IN THIS PROCEDURE? WOULD THE SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL AND ENGINEERING (TRANSLATION IS AVAILABLE)? CITATION: NEUROL INDIA. 2013; 61: 692-3. DOI: 10.4103/0028-3886.125391.

    Description of Event or Problem · 1

    TITLE: ANTERIOR CERVICAL MENINGOMYELOCELE IN A NEONATE. AUTHORS: G SRIHARI, HOSMANI SHARAN BASAPPA, BADA VIJAY KUMAR, PN HARISH CITATION: NEUROL INDIA. 2013; 61: 692-3. DOI: 10.4103/0028-3886.125391. A (B)(6) -OLD BABY GIRL PRESENTED WITH REPEATED RESPIRATORY TRACT INFECTIONS AT ANOTHER FACILITY. CHEST X-RAY REVEALED RIGHT LUNG HAZINESS. SUSPECTING RIGHT PLEURAL EFFUSION, INADVERTENTLY RIGHT INTERCOSTAL DRAIN (ICD) WAS PLACED AND CLEAR CEREBROSPINAL FLUID (CSF) WAS DRAINED. SUBSEQUENTLY, THE CHILD WAS REFERRED TO THE CENTER. MAGNETIC RESONANCE IMAGING OF THE ENTIRE SPINE SHOWED LARGE ANTERIOR CERVICAL MENINGOMYELOCELE (ACM) AT C6 LEVEL EXTENDING INFERIORLY INTO THE POSTERIOR MEDIASTINUM AND CAUSING RIGHT LUNG COLLAPSE AND HYDROTHORAX. CONSIDERING THE AGE AND POOR GENERAL CONDITION, SHE WAS PLANNED FOR A SIMPLE LIGATION OF THE SAC AND DISCONNECTION OF THE DISTAL SAC. DURING THE SURGICAL PROCEDURE, THE NECK OF THE SAC WAS LIGATED IN FLUSH WITH VERTEBRAL BODY DEFECT WITH MERSILK SUTURE AND DISCONNECTED FROM THE REST OF THE SAC. IMMEDIATE POST-OPERATIVELY, THE PATIENT HAD ICD SITE INFECTION AS CULTURE SHOWED KLEBSIELLA PNEUMONIAE SENSITIVE TO THE DRUG WHICH WAS TREATED WITH CEFOPERAZONE. BLOOD CULTURE GREW CANDIDIASIS WHICH WAS TREATED WITH FLUCONOAZOLE. AFTER EXTENDED STAY IN THE INTENSIVE CARE UNIT FOR 4 WEEKS, THE PATIENT¿S ESOPHAGEAL FISTULA AND ICD SITE FISTULA CLOSED SPONTANEOUSLY. HOWEVER, SHE HAD REPEATED EPISODES OF BREATHLESSNESS AND FALL IN SATURATION, WHICH WERE DUE TO ASPIRATION/INFECTIONS AND WERE MANAGED WITH BRONCHODILATORS, ANTIBIOTICS, AND CHEST PHYSIOTHERAPY. TWO MONTHS AFTER DISCHARGE, THE PATIENT EXPIRED PRESUMABLY DUE TO HYPOXIA/ASPIRATION/SEPSIS. IT WAS CONCLUDED THAT THE ANTERIOR CERVICAL APPROACH SEEMS TO BE THE MOST DIRECT APPROACH FOR ADDRESSING THE ANTERIOR CERVICAL MENINGOCELES. THE PRESENT CASE DEMONSTRATES THE CHALLENGES IN THE MANAGEMENT OF THIS RARE CLINICAL ENTITY WHEN ENCOUNTERED IN AN INFANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535112 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death