BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SPIRAL MONOCRYL PLUS UNKNOWN

    MDR report key: 24251213 · Received February 3, 2026

    Report

    Report Number
    2210968-2026-01263
    Event Type
    Injury
    Date Received
    February 3, 2026
    Date of Event
    August 8, 2025
    Report Date
    February 3, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: J CLIN MED. 2025 AUG 8;14(16):5630. DOI: 10.3390/JCM14165630. PMID: 40869456; PMCID: PMC12386738. HTTPS://DOI.ORG/10.3390/JCM14165630.

    Description of Event or Problem · 0

    MEDIAL THIGH LIFT WITH TUMESCENT LOCAL ANESTHESIA: ADVANCING OUTPATIENT BODY CONTOURING. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO ASSESS THE FEASIBILITY, SAFETY, AND OUTCOMES OF MEDIAL THIGH LIFT PERFORMED EXCLUSIVELY UNDER TUMESCENT LOCAL ANESTHESIA (TLA) IN AN OUTPATIENT SETTING. A TOTAL OF 43 FEMALE PATIENTS (MEAN AGE OF 41.6 YEARS; BMI OF 27.6 KG/M2) TREATED FROM NOVEMBER 2019 TO JUNE 2023 WERE INCLUDED IN THE STUDY. AMONG THESE PATIENTS, 30 UNDERWENT COMBINED MEDIAL THIGH LIFT WITH CONCURRENT LIPOSUCTION, WHILE 13 RECEIVED MEDIAL THIGH LIFT ALONE. DEEP DISSECTION PROCEEDED TO IDENTIFY COLLES¿ FASCIA, WHICH WAS ANCHORED TO THE DERMAL LAYER OF BOTH WOUND MARGINS USING 2-0 VICRYL SUTURES, IN ACCORDANCE WITH LOCKWOOD¿S PRINCIPLES. NO UNDERMINING, DE-EPITHELIALIZATION, OR DRAIN PLACEMENT WAS PERFORMED. CLOSURE WAS PERFORMED USING BARBED MONOFILAMENT RUNNING IN A SUBCUTICULAR SUTURE (3-0 MONOCRYL). A LIGHT COMPRESSIVE DRESSING AND A STANDARDIZED ELASTIC COMPRESSION GARMENT WERE APPLIED. REPORTED COMPLICATIONS INCLUDE: P02: 36-YEAR-OLD FEMALE (N=1) - HYPERTROPHIC SCAR TREATMENT: TREATED USING SILICONE GEL SHEETS AND CORTICOSTEROID INFILTRATION. IN CONCLUSION, MEDIAL THIGH LIFT UNDER PURE TLA PROVIDES RELIABLE ANESTHESIA AND HEMOSTASIS, MINIMIZES PERIOPERATIVE MORBIDITY, AND ENABLES SAME-DAY DISCHARGE, WITH HIGH PATIENT SATISFACTION. THE LOW INCIDENCE OF ONLY MINOR COMPLICATIONS SUPPORTS TLA AS A SAFE, EFFECTIVE, AND RESOURCE-EFFICIENT ALTERNATIVE TO GENERAL ANESTHESIA FOR SELECTED PATIENTS WITH MILD-TO-MODERATE THIGH LAXITY. FURTHER COMPARATIVE AND LONG-TERM STUDIES ARE WARRANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307439 STRATAFIX SPIRAL MONOCRYL PLUS UNKNOWN SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention