BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 23019011 · Received September 10, 2025

    Report

    Report Number
    2210968-2025-10323
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    November 2, 2024
    Report Date
    September 19, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: AESTHET SURG J. 2025 FEB 18;45(3):225-231. HTTPS://DOI.ORG/10.1093/ASJ/SJAE224 PMID: 39487802.

    Description of Event or Problem · 0

    TITLE: THE GLIDING BROW LIFT: AN ANALYSIS OF OUTCOMES AND MAINTENANCE OF LIFT IN A SINGLE SURGEON'S PRACTICE. THE AIM OF THIS STUDY IS TO EVALUATE MAINTENANCE OF CUTANEOUS BROW ELEVATION WITH THE GBL TECHNIQUE AT SPECIFIC POSTOPERATIVE TIME POINTS. BETWEEN 2019 AND 2022, A TOTAL OF 59 FEMALE-ONLY PATIENTS (118 BROWS) WHO UNDERWENT A GBL (GLIDING BROW LIFT) USING 4-0 PROLENE (ETHICON, RARITAN, NJ) SUTURES. REPORTED COMPLICATIONS ARE: N = 3; INFECTION. TREATMENT: ANTIBIOTICS, NEUROTOXIN INJECTION, TOPICAL STEROIDS, OR KENALOG. N = 3; SKIN CHANGES SUCH AS SCARRING OR IRRITATION. TREATMENT: ANTIBIOTICS, NEUROTOXIN INJECTION, TOPICAL STEROIDS, OR KENALOG. N = 3; TEMPORAL FULLNESS. TREATMENT: TREATMENT: ANTIBIOTICS, NEUROTOXIN INJECTION, TOPICAL STEROIDS, OR KENALOG. IN CONCLUSION, THE GBL IS A SUCCESSFUL INNOVATION IN AESTHETIC BROW SURGERY. DEPENDING ON PATIENT NEEDS, IT IS AN EXCELLENT CHOICE FOR SELECTIVE AND LONG-TERM ELEVATION OF THE LATERAL BROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061229 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention