BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24318834 · Received February 11, 2026

    Report

    Report Number
    2210968-2026-01566
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    April 29, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: SAGE OPEN MED CASE REP. 2025 APR 29;13:2050313X251338563. DOI: 10.1177/2050313X251338563. PMID: 40308379; PMCID: PMC12041720. HTTPS://DOI.ORG/10.1177/2050313X251338563.

    Description of Event or Problem · 0

    INTRATHECAL DRUG DELIVERY SYSTEMS: A CASE SERIES ADVANCING SURGICAL, CLINICAL, AND TECHNOLOGICAL SAFETY WITH BROADER IMPLICATIONS FOR INVASIVE NEUROMODULATION THERAPIES. IN THIS SERIES, THE AUTHORS PRESENT THREE CASES THAT UNDERSCORE THE NECESSITY OF MITIGATING HARM ASSOCIATED WITH INTRATHECAL DRUG DELIVERY SYSTEMS (IDDS) THERAPY. THESE CASES (A 77-YEAR-OLD MALE, 37-YEAR-OLD FEMALE, AND 67-YEAR-OLD FEMALE) HIGHLIGHT THE CRITICAL IMPORTANCE OF EARLY DETECTION OF NEUROLOGICAL CHANGES IN PATIENTS WITH COMPLEX COMORBIDITIES, THE IMPERATIVE OF SURGICAL COMPETENCE AND ADHERENCE TO STRINGENT PERIOPERATIVE ANTIMICROBIAL PROTOCOLS, AND THE EVOLVING ROLE OF PHYSICIAN LEADERSHIP IN MAINTAINING TECHNOLOGICAL SAFEGUARDS IN AN ERA OF RAPID INNOVATION IN INVASIVE THERAPEUTIC MODALITIES. REPORTED COMPLICATIONS INCLUDE: 2¿0 VICRYL SUTURE (ETHICON): CASE 2: A 37-YEAR-OLD FEMALE (N=1) - WOUND ERYTHEMA; A 2¿0 VICRYL SUTURE KNOT WAS NOTED PROTRUDING FROM THE CATHETER INSERTION CLOSURE SITE TREATMENT: WHICH TRIMMED BY THE EVALUATING FELLOW DURING HER WOUND CHECK. THE WOUND WAS MANAGED CONSERVATIVELY VIA SERIAL OBSERVATION. - TWO WEEKS LATER, THE PATIENT PRESENTED IN SEPTIC SHOCK WITH NEUROLOGICAL SIGNS CONSISTENT WITH ACUTE BACTERIAL MENINGITIS, INCLUDING PHOTOPHOBIA, HEADACHE, AND NUCHAL RIGIDITY. ON EXAMINATION, SIGNIFICANT WOUND ERYTHEMA AND INDURATION WERE NOTED AT THE CATHETER AND PUMP INCISION SITES, ALONG WITH TENDERNESS AND WARMTH IN THE LUMBAR AND LUMBOSACRAL REGIONS. TREATMENT: EMERGENT IDDS EXPLANTATION, WOUND DEBRIDEMENT/WASHOUT, AND INITIATION OF EMPIRICAL INTRAVENOUS VANCOMYCIN AND CEFTRIAXONE THERAPY FOLLOWING CONSULTATION WITH INFECTIOUS DISEASE. INTRAOPERATIVE FINDINGS REVEALED COPIOUS PURULENT FLUID AT BOTH THE LUMBAR CATHETER INSERTION SITE (FIGURE 2) AND THE ADJACENT DEVICE POCKET (FIGURE 3), WITH EVIDENCE OF COMMUNICATION BETWEEN THE TWO SITES VIA DEFECTS IN THE SOFT TISSUE LAYERS. INTRAOPERATIVE CSF CULTURES LATER CONFIRMED STAPHYLOCOCCUS EPIDERMIDIS AS THE PATHOGEN. THE PATIENT REMAINED HOSPITALIZED FOR 2 WEEKS POSTOPERATIVELY UNTIL REMOVAL OF THE SUPERFICIAL RETENTION SUTURE AND COMPLETION OF A 6-WEEK COURSE OF TARGETED INTRAVENOUS VANCOMYCIN THERAPY VIA A PERIPHERALLY INSERTED CENTRAL CATHETER. SHE ULTIMATELY RECOVERED WITHOUT PERMANENT NEUROLOGICAL SEQUELAE, AND 6 MONTHS POSTOPERATIVELY SHE RESUMED CARE WITH HER PRIMARY PAIN SPECIALIST, RECEIVING A SUBSEQUENT IDDS IMPLANT 12 MONTHS LATER WITHOUT PERIOPERATIVE COMPLICATIONS. IN CONCLUSION, THIS ANALYSIS DELINEATES THREE CRITICAL DOMAINS: FIRST, CLINICAL VIGILANCE AND ENHANCED MONITORING PROTOCOLS ARE ESSENTIAL FOR THE EARLY IDENTIFICATION OF SEVERE COMPLICATIONS, SUCH AS GRANULOMA FORMATION; SECOND, AN EDUCATIONAL PARADIGM SHIFT, STANDARDIZED, COMPREHENSIVE SURGICAL TRAINING IN FELLOWSHIP PROGRAMS IS REQUIRED TO ENSURE TECHNICAL PROFICIENCY, OPTIMAL POSTOPERATIVE MANAGEMENT, AND AN IN-DEPTH UNDERSTANDING OF PSYCHOSOCIAL FACTORS; AND THIRD, TECHNOLOGICAL LEADERSHIP, THE ADOPTION OF APP-BASED MANAGEMENT SYSTEMS ON CONSUMER PLATFORMS INTRODUCES VULNERABILITIES INCLUDING SOFTWARE MALFUNCTIONS AND CYBERSECURITY THREATS, THEREBY NECESSITATING THAT PHYSICIANS ADVOCATE FOR STRINGENT SAFETY STANDARDS AND ROBUST REGULATORY OVERSIGHT. COLLECTIVELY, THESE STRATEGIES ARE INDISPENSABLE FOR ENHANCING THE SAFETY AND EFFICACY OF INVASIVE NEUROMODULATION THERAPIES AND TRANSFORMING THE LANDSCAPE OF CHRONIC PAIN MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373646 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention