BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 16574414 · Received March 20, 2023

    Report

    Report Number
    2210968-2023-01810
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    September 30, 2022
    Report Date
    March 20, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. *EVENTS WERE REPORTED OF CUTANEOUS CSF FISTULA AND PSEUDOMENINGOCELE (N=1) IN A 12-YEAR-OLD GIRL AND POSTOPERATIVE PSEUDOMENINGOCELES (N=5). THE ARTICLE STATES THAT ETHIBOND EXCEL OR TI-CRON WERE USED TO CLOSE THE DURA. PLEASE CONFIRM WHICH OF THESE DEVICES (ETHIBOND OR TI-CRON) WERE SPECIFICALLY USED IN THESE PATIENTS THAT CAUSED THIS EVENTS. *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. ADVERSE EVENT PROBLEM COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2023-01809, 2210968-2023-01811, 2210968-2023-01812. CITATION: J NEUROSURG PEDIATR (SEPTEMBER 30, 2022); HTTPS://THEJNS.ORG/DOI/ABS/10.3171/2022.8.PEDS22270.

    Description of Event or Problem · 0

    TITLE: WOUND CLOSURE WITH A MESH AND LIQUID TISSUE ADHESIVE (DERMABOND PRINEO) SYSTEM IN PEDIATRIC SPINE SURGERY: A PROSPECTIVE SINGLE-CENTER COHORT STUDY INCORPORATING PARENT-REPORTED OUTCOME MEASURES. THE AIM OF THIS PROSPECTIVE SINGLE-CENTER COHORT STUDY WAS TO INVESTIGATE THE EFFICIENCY AND COSMETIC OUTCOME OF DP FOR WOUND CLOSURE IN PEDIATRIC NEUROLOGICAL SPINE SURGERY. BETWEEN JANUARY 2018 AND APRIL 2022, A TOTAL OF 47 CHILDREN (29 GIRLS; MEAN AGE OF 6.5 ± 5.9 YEARS) UNDERWENT INTRA- AND EXTRADURAL NEUROLOGICAL SPINE SURGERY (50 SURGERIES) WITH USE OF DERMABOND PRINEO (DP) (ETHICON INC.) FOR WOUND CLOSURE. IN ALL INTRADURAL CASES, THE DURA WAS CLOSED USING A RUNNING NONABSORBABLE SUTURE WITH EITHER ETHIBOND EXCEL (ETHICON, JOHNSON & JOHNSON) OR TI-CRON (COVIDIEN, MEDTRONIC). THEREAFTER, AN ADHESIVE SEALANT (TACHOSEAL, CORZA MEDICAL GMBH) WAS APPLIED TOGETHER WITH FIBRIN GLUE (TISSEEL, BAXTER) ON THE DURAL SURFACE. FACIAL AND SUBCUTANEOUS LAYERS WERE THEN CLOSED METICULOUSLY WITH INTERRUPTED RESORBABLE SUTURES (VICRYL, ETHICON, JOHNSON & JOHNSON). AS SUGGESTED BY THE MANUFACTURER, BEFORE APPLYING DP IN A TWO-STEP PROCESS, GREAT CARE MUST BE TAKEN THAT THE APPROXIMATION AND ALIGNMENT OF THE SKIN LAYERS, ESPECIALLY THE EPIDERMAL EDGES, ARE EXACT AND SUFFICIENT (FIG. 1A). THE DP SKIN CLOSURE SYSTEM CONSISTS OF SELF-ADHESIVE MESH FOR APPROXIMATION OF THE WOUND EDGES WITHOUT THE NEED FOR AN INTRADERMAL SUTURE AND TISSUE GLUE, WHICH PROVIDES A PROTECTIVE FILM WITH A SEALING EFFECT. REPORTED COMPLICATIONS INCLUDE CUTANEOUS CSF FISTULA AND PSEUDOMENINGOCELE (N=1; 12-YEAR-OLD GIRL) AND UNDERWENT REVISION SURGERY, MINIMAL CUTANEOUS DEHISCENCE AT ONE END OF THE SURGICAL INCISION (N=10) REQUIRING APPLICATION OF STERI-STRIPS (3M) IN 9 AND A STITCH IN 1 CASE, MACERATION OF A CUTANEOUS HEMANGIOMA ADJACENT TO THE SURGICAL WOUND (N=1), AND POSTOPERATIVE PSEUDOMENINGOCELES (N=5). IN CONCLUSION, THE APPLICATION OF DP IS SIMPLE, ENABLES GOOD PATIENT COMFORT, FACILITATES BOTH PROFESSIONAL AND PARENTAL WOUND CARE, AND LEADS TO EXCELLENT COSMETIC RESULTS. DP POSSIBLY AIDS IN THE REDUCTION OF POSTOPERATIVE CSF LEAKAGE AND INFECTIONS AFTER PEDIATRIC NEUROLOGICAL SPINE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953490 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention