BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 16620763 · Received March 27, 2023

    Report

    Report Number
    2210968-2023-02088
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    October 8, 2022
    Report Date
    March 27, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2023-02078, 2210968-2023-02082, 2210968-2023-02087, 2210968-2023-02089, 2210968-2023-02090, 2210968-2023-02091 AND 2210968-2023-02093. CITATION: INT. J. ENVIRON. RES. PUBLIC HEALTH 2022, 19, 12897. HTTPS://DOI.ORG/10.3390/IJERPH191912897.

    Description of Event or Problem · 0

    TITLE: CLINICAL FEATURES AND TREATMENT OF INTRA-TENDINOUS SUTURE REACTION FOLLOWING ACHILLES TENDON REPAIR USING NONABSORBABLE SUTUREMATERIAL: A RETROSPECTIVE CASE SERIES STUDY. THIS STUDY AIMED TO INVESTIGATE THE CLINICAL MANIFESTATIONS, RADIOLOGICAL FINDINGS, AND THERAPEUTIC OUTCOME OF TREATMENT FOR PATIENTS WITH SURGICALLY CONFIRMED FOREIGN BODY REACTION FOLLOWING AN ACHILLES TENDON REPAIR USING NON-ABSORBABLE SUTURE MATERIAL. FROM JANUARY 2017 TO DECEMBER 2020, 8 PATIENTS WHO WERE SURGICALLY CONFIRMED TO HAVE A FOREIGN BODY REACTION AROUND A PREVIOUSLY REPAIRED ACHILLES TENDON WERE INCLUDED IN THE STUDY. THERE WERE 5 MALES AND 3 FEMALES WITH A MEAN AGE OF 46.6 +/- 13.1 YEARS (RANGE, 24¿62 YEARS). THE SUTURE MATERIAL USED DURING THE SURGERY WAS NONABSORBABLE MATERIAL ETHIBOND (ETHICON) IN ALL PATIENTS. ALL THE PATIENTS UNDERWENT SURGICAL EXCISION OF FOREIGN BODY REACTION TISSUE AND PRIMARY REPAIR USING ABSORBABLE SUTURE MATERIAL (MANUFACTURER: UNKNOWN). AFTER THE TREATMENT, THE WOUNDS WERE HEALED COMPLETELY IN ALL. THE REPORTED COMPLICATIONS INCLUDED A 53-YEAR-OLD MALE COMPLAINING OF PAIN WITH GRANULATION TISSUE AND FOREIGN BODY REACTION TO THE NONABSORBABLE SUTURE (N=1), A 47- YEAR-OLD MALE COMPLAINING OF PAIN WITH GRANULATION TISSUE AND FOREIGN BODY REACTION TO THE NONABSORBABLE SUTURE (N=1), A 60-YEAR-OLD MALE COMPLAINING OF PAIN WITH GRANULATION TISSUE AND FOREIGN BODY REACTION TO THE NONABSORBABLE SUTURE (N=1), A 33-YEAR-OLD MALE COMPLAINING OF PAIN WITH GRANULATION TISSUE AND FOREIGN BODY REACTION TO THE NONABSORBABLE SUTURE (N=1), A 24-YEAR-OLD FEMALE COMPLAINING OF PAIN WITH GRANULATION TISSUE AND FOREIGN BODY REACTION TO THE NONABSORBABLE SUTURE (N=1), A 52-YEAR-OLD FEMALE COMPLAINING OF PAIN WITH GRANULATION TISSUE AND FOREIGN BODY REACTION TO THE NONABSORBABLE SUTURE (N=1), A 62-YEAR-OLD MALE COMPLAINING OF PAIN WITH GRANULATION TISSUE AND FOREIGN BODY REACTION TO THE NONABSORBABLE SUTURE (N=1), AND A 42-YEAR-OLD FEMALE COMPLAINING OF PAIN WITH GRANULATION TISSUE AND FOREIGN BODY REACTION TO THE NONABSORBABLE SUTURE (N=1). IN CONCLUSION, INTRA-TENDINOUS SUTURE REACTION IS A RARE COMPLICATION FOLLOWING AN ACHILLES TENDON REPAIR USING NONABSORBABLE SUTURE MATERIAL, BUT IT CAN BE TREATED ADEQUATELY WITH ONLY SURGICAL EXCISION OF FOREIGN BODY REACTION TISSUE AND PRIMARY REPAIR USING ABSORBABLE SUTURE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691332 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention