BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 19122568 · Received April 16, 2024

    Report

    Report Number
    2210968-2024-04400
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    March 24, 2023
    Report Date
    April 16, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: J NEUROSURG PEDIATR 32:106¿114, 2023; HTTPS://DOI.ORG/10.3171/2023.2.PEDS22457.

    Description of Event or Problem · 0

    TITLE: THE SIGNIFICANCE OF HINDBRAIN HERNIATION REVERSAL FOLLOWING PRENATAL REPAIR OF NEURAL TUBE DEFECTS. THE AIM OF THIS STUDY WAS TO DETERMINE WHETHER REVERSAL OF HINDBRAIN HERNIATION ON MAGNETIC RESONANCE IMAGING (MRI) FOLLOWING PRENATAL REPAIR OF NEURAL TUBE DEFECTS IS ASSOCIATED WITH REDUCED RATES OF VENTRICULOPERITONEAL SHUNT PLACEMENT OR ENDOSCOPIC THIRD VENTRICULOSTOMY WITHIN THE 1ST YEAR OF LIFE. BETWEEN 2012 AND 2020, 78 PATIENTS WHO HAD PRENATAL OPEN REPAIR OF FETAL NEURAL TUBE DEFECTS WERE INCLUDED IN THE STUDY. THERE WERE 42 MALES AND 35 FEMALES. PATIENTS WERE OFFERED SURGERY ACCORDING TO INCLUSION CRITERIA FROM THE MANAGEMENT OF MYELOMENINGOCELE STUDY (MOMS). AFTER EXTENSIVE COUNSELING, OPEN FETAL REPAIR WAS OFFERED TO SURGICAL CANDIDATES AND PERFORMED DURING THE 22ND¿25TH WEEKS OF GESTATION. DURING THE PROCEDURE, THE PLACENTA WAS CAREFULLY MAPPED USING INTRAOPERATIVE ULTRASOUND, AND A HYSTEROTOMY WAS MADE WITH A NON-ETHICON UTERINE STAPLER (MANUFACTURER: UNKNOWN) AT LEAST 6 CM AWAY FROM THE PLACENTAL EDGE. NEURAL TUBE DEFECT REPAIR INVOLVED DISSECTION OF THE SKIN AT THE JUNCTIONAL ZONE AND FULL-THICKNESS CIRCUMFERENTIAL SKIN MOBILIZATION. THE DURA MATER WAS CLOSED IN A RUNNING FASHION WITH A MONOCRYL (ETHICON) SUTURE. THE SKIN WAS CLOSED SEPARATELY USING A MONOCRYL (ETHICON) SUTURE ALSO IN A RUNNING FASHION, BUT WITH THE ADDITION OF HORIZONTAL MATTRESS SUTURES TO HELP RELIEVE TENSION IN CASES WHERE IT WAS REQUIRED. NON-ETHICON SYNTHETIC PATCHES (ACELLULAR BOVINE SKIN MATRIX, MANUFACTURER: UNKNOWN) WERE USED FOR THE SKIN IF REQUIRED TO ENSURE A TENSION-FREE CLOSURE. A PATCH WAS ALSO USED FOR THE DURA IN 7 CASES. FOLLOWING SURGERY, PATIENTS RECOVERED IN THE HOSPITAL FOR 4¿5 DAYS PRIOR TO DISCHARGE. FURTHER PRENATAL CARE, INCLUDING WEEKLY POSTOPERATIVE ULTRASOUND SURVEILLANCE, WAS PERFORMED. DELIVERY AND POSTNATAL CARE, INCLUDING PEDIATRIC NEUROSURGICAL MANAGEMENT OF HYDROCEPHALUS, WAS PROVIDED AT A HOSPITAL LOCAL TO THE PATIENT¿S PLACE OF RESIDENCE WITH A LEVEL IV NEONATAL INTENSIVE CARE UNIT (NICU) AND APPROPRIATE PEDIATRIC NEUROSURGICAL COVERAGE. THE DECISION TO PERFORM CSF DIVERSION WAS MANAGED BY THE PATIENT¿S LOCAL PEDIATRIC NEUROSURGEONS. ON POSTNATAL MRI, 38 HAD HINDBRAIN HERNIATION REVERSAL AND 40 HAD PERSISTENT HINDBRAIN HERNIATION. REPORTED COMPLICATIONS INCLUDED INTRAVENTRICULAR HEMORRHAGE (N=2), CEREBROSPINAL FLUID LEAKAGE (N=?), REPAIR DEHISCENCE (N=?), HYDROCEPHALUS (N=?), AND CEREBELLAR COMPRESSION (N=?). IN CONCLUSION, HINDBRAIN HERNIA REVERSAL WAS NOT ASSOCIATED WITH DECREASED RATES OF CEREBROSPINAL FLUID DIVERSION IN THIS COHORT. PREDICTIVE ACCURACY OF THE ANTICIPATED BENEFITS OF PRENATAL NEURAL TUBE DEFECT REPAIR MAY NOT BE AUGMENTED BY THE OBSERVATION OF HINDBRAIN HERNIA REVERSAL ON MAGNETIC RESONANCE IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062137 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention