BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 21940265 · Received April 30, 2025

    Report

    Report Number
    2210968-2025-04761
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    September 15, 2024
    Report Date
    May 8, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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. CITATATION: CUREUS. 2024 SEP 15;16(9): E69436. HTTPS://DOI.ORG/10.7759/CUREUS.69436. PMID: 39411607; PMCID: PMC11474413.

    Description of Event or Problem · 0

    TITLE: ORTHOPEDIC SKIN CLOSURE IN SOUTH INDIA: SUTURES VERSUS STAPLES AND THEIR POSTOPERATIVE OUTCOMES. THE AIM OF THIS STUDY IS TO COMPARING THE OUTCOME OF WOUND CLOSURE IN ORTHOPEDIC SURGERIES WITH SUTURES AND STAPLES IN A SOUTH INDIAN POPULATION. BETWEEN JULY 2023 TO FEBRUARY 2024, A TOTAL OF 120 PATIENTS UNDERGOING ORTHOPEDIC PROCEDURES AT CHETTINAD HOSPITAL AND RESEARCH INSTITUTE. THE COHORT INCLUDED 67 MALES AND 53 FEMALES WITH A MEAN AGE OF 41 YEARS (RANGE 24-58 YEARS). PATIENTS WERE RANDOMLY ASSIGNED TO SKIN CLOSURE WITH EITHER STAPLES OR SUTURES. WOUND INSPECTION WAS DONE ON THE 2 ND , 5 TH , 7 TH AND 12 TH POST-OPERATIVE DAYS. THE PATIENTS WERE EVALUATED AT SIX MONTHS USING THE VISUAL ANALOG SCALE (VAS) AND HOLLANDER WOUND EVALUATION SCORE (HWES). VICRYL SUTURES(ABSORBABLE POLYGLACTIN 910; ETHICON) IS USED FOR WOUND CLOSURE UP TO THE SUBCUTANEOUS LAYER AND EITHER STAPLES OR NON-ABSORBABLE NYLON (ETHILON SUTURES; ETHICON) IS USED FOR SKIN CLOSURE. REPORTED COMPLICATIONS ARE : VICRYL SUTURES (ABSORBABLE POLYGLACTIN 910; ETHICON): WOUND COMPLICATIONS (N=14). TREATMENT : NOT PROVIDED INFECTION (N=6). TREATMENT: NOT PROVIDED DISCHARGE FROM WOUND (N=4). TREATMENT: NOT PROVIDED WOUND NECROSIS (N=1). TREATMENT: NOT PROVIDED -HYPERTROPHIC SCAR FORMATION (N=3) . TREATMENT : NOT PROVIDED ETHILON SUTURES (NON-ABSORBABLE NYLON; ETHICON): -WOUND COMPLICATIONS (N=9). TREATMENT : NOT PROVIDED INFECTION (N=4). TREATMENT: NOT PROVIDED DISCHARGE FROM WOUND (N=2). TREATMENT: NOT PROVIDED WOUND NECROSIS (N=1) . TREATMENT: NOT PROVIDED HYPERTROPHIC SCAR FORMATION (N=2). TREATMENT: NOT PROVIDED. IN CONCLUSION, COMPARATIVE ANALYSIS OF SUTURES VERSUS STAPLES FOR SKIN CLOSURE IN ORTHOPEDIC SURGERIES, STAPLES DEMONSTRATED NOTABLE ADVANTAGES, INCLUDING A SIGNIFICANTLY SHORTER CLOSURE TIME AND LESS PAIN DURING REMOVAL. STAPLES PROVIDED BETTER COSMETIC OUTCOMES WITHOUT INCREASING THE RISK OF COMPLICATIONS SUCH AS INFECTION OR HYPERTROPHIC SCARRING. WHILE PATIENT SATISFACTION REMAINED COMPARABLE ACROSS BOTH METHODS, THE EFFICIENCY AND AESTHETIC BENEFITS OF STAPLES EMPHASIZE THEIR POTENTIAL SUPERIORITY IN SURGICAL SKIN CLOSURE. FUTURE STUDIES WITH LONGER FOLLOW-UP ARE WARRANTED TO CONFIRM THESE FINDINGS AND EXPLORE LONG-TERM IMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024210 ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other