BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12540812 · Received September 28, 2021

    Report

    Report Number
    2210968-2021-08902
    Event Type
    Injury
    Date Received
    September 28, 2021
    Date of Event
    May 11, 2021
    Report Date
    September 10, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: J. CLIN. MED. 2021, 10, 2054. PAGES 1-12 HTTPS://DOI.ORG/10.3390/JCM10102054.

    Description of Event or Problem · 1

    TITLE: INTRACAMERAL BEVACIZUMAB VERSUS SUB-TENON¿S MITOMYCIN C AS ADJUNCTS TO TRABECULECTOMY: 3-YEAR RESULTS OF A PROSPECTIVE RANDOMIZED STUDY. THIS STUDY COMPARES INTRACAMERAL BEVACIZUMAB TO SUB-TENON¿S MITOMYCIN C (MMC) IN TRABECULECTOMY. BETWEEN JANUARY 2012 AND MAY 2015, 100 PATIENTS WITH MEDICALLY UNCONTROLLED GLAUCOMA OR INTOLERANCE TO GLAUCOMA MEDICATIONS WERE INCLUDED IN THE STUDY. THERE WERE 50 PATIENTS ASSIGNED TO THE BEVACIZUMAB GROUP AND 50 PATIENTS TO THE MMC (CONTROL) GROUP. IN THE BEVACIZUMAB GROUP, THERE WERE 27 MALES AND 23 FEMALES WITH A MEAN AGE OF 71+/-12.6 YEARS. IN THE MMC GROUP, THERE WERE 25 MALES AND 25 FEMALES WITH A MEAN AGE OF 70.1+/-10.2 YEARS. SURGERY WAS PERFORMED UNDER TOPICAL ANESTHESIA BY A SINGLE SURGEON USING IDENTICAL SURGICAL TECHNIQUE EXCEPT FOR THE TYPE OF ANTIMETABOLITE/ANTIFIBROTIC AGENT EMPLOYED. DURING THE SURGERY, 2 PREPLACED 8-0 VICRYL SUTURES (ETHICON) WERE USED TO SECURE THE SCLERAL FLAP. ALL PATIENTS WERE EXAMINED ON THE FIRST DAY AFTER SURGERY AND THEN EVERY WEEK FOR THE FIRST MONTH, EVERY 3 MONTHS FOR THE FIRST YEAR AND EVERY 6 MONTHS THEREAFTER, UNTIL THEY REACHED 36 MONTHS OF FOLLOW-UP. COMPLICATIONS INCLUDE: CHOROIDAL EFFUSION (N=11), TRANSIENT HYPOTONY LESS THAN 1 MONTH (N=17), HYPHEMA (N=5), SHALLOW ANTERIOR CHAMBER (N=10), EARLY BLEB LEAK (N=3), BLEBITIS (N=1), FAILING BLEBS REQUIRING REOPERATION (N=3), AND INTRAOCULAR REDUCTION LESS THAN 20 PERCENT (N=8). IN CONCLUSION, INTRACAMERAL BEVACIZUMAB APPEARS TO PROVIDE SIMILAR LONG-TERM EFFICACY AND SAFETY RESULTS AS SUB-TENON¿S MITOMYCIN C AFTER TRABECULECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436084 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention