BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22184838 · Received June 11, 2025

    Report

    Report Number
    2210968-2025-06613
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    September 2, 2024
    Report Date
    June 11, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IZ
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: RADIOL CASE REP. 2024 SEP 25;19(12):6313-6317. HTTPS://DOI.ORG/10.1016/J.RADCR.2024.09.003. PMID: 39387021; PMCID: PMC11461947.

    Description of Event or Problem · 0

    TITLE: POSTENDOSCOPIC SPINE SURGERY BACTERIAL MENINGITIS REQUIRING MULTIPLE SURGICAL INTERVENTIONS: A COMPLEX CASE REPORT. THE AIM OF THIS STUDY IS TO PRESENT A CASE OF A 43-YEAR-OLD FEMALE PATIENT WHO EXPERIENCED BACTERIAL MENINGITIS FOLLOWING ENDOSCOPIC SURGICAL INTERVENTION FOR LUMBAR DISC HERNIATION. VICRYL 6/0 (ETH) WAS USED TO REPAIRED THE DURAL TEAR. REPORTED COMPLICATIONS: VICRYL 6/0 (ETH) 43-YEAR OLD FEMALE (N=1) SCANT SURGICAL SITE FLUID DISCHARGE TREATMENT: ANTIBIOTICS SURGICAL SITE INFECTION TREATMENT: ANTIBIOTICS MECHANICAL BACK PAIN TREATMENT: TRANSFORAMINAL LUMBAR INTER-BODY FUSION PROCEDURE DISCITIS TREATMENT: TRANSFORAMINAL LUMBAR INTER-BODY FUSION PROCEDURE IN CONCLUSION, THE CASE REPORT SHEDS LIGHT ON AN UNUSUAL OCCURRENCE OF BACTERIAL MENINGITIS FOLLOWING ENDOSCOPIC SPINAL SURGERY, A COMPLICATION THAT HAS BEEN PREDOMINANTLY ASSOCIATED WITH OPEN PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103266 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention