BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 16077471 · Received December 30, 2022

    Report

    Report Number
    2210968-2022-10789
    Event Type
    Injury
    Date Received
    December 30, 2022
    Date of Event
    January 13, 2022
    Report Date
    December 30, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. (B)(4). DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-10790. CITATION: OPHTHALMIC PLAST RECONSTR SURG, VOL. 38, NO. 5, 2022. HTTPS://DOI.ORG/10.1097/IOP.0000000000002159.

    Description of Event or Problem · 0

    TITLE: LATERAL TARSAL STRIP COMPLICATIONS WITH AND WITHOUT CONJUNCTIVA STRIPPING. THE AUTHORS OF THE STUDY SOUGHT TO RETROSPECTIVELY COMPARE THE COMPLICATION RATES FOR LATERAL TARSAL STRIP PROCEDURES PERFORMED WITH AND WITHOUT TARSAL CONJUNCTIVA REMOVAL. BETWEEN JULY 2016 AND JUNE 2021, 168 PATIENTS (71 BILATERAL) WHO UNDERWENT LATERAL TARSAL STRIP PROCEDURES (239 OPERATIONS) WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO 2 GROUPS, CON (CONJUNCTIVA NOT REMOVED, 105 OPERATIONS) OR COFF (CONJUNCTIVAL REMOVED, 134OPERATIONS). MEAN AGE WAS 75.8 YEARS OLD ± 0.87 (RANGE 24¿97), FEMALE GENDER MADE 48.2 PERCENT OF THE COHORT, AND 50.2 PERCENT WERE LEFT-SIDED PROCEDURES. DURING THE PROCEDURE, 2 SUTURE TYPES WERE USED FOR ANCHORING THE TARSAL STRIP TO THE PERIOSTEUM: 4-0 AND 5-0 POLYGLACTIN 910 SUTURES (VICRYL, ETHICON) AND 4-0 AND 5-0 ETHYLENE TEREPHTHALATE (MERSILENE, ETHICON) WERE USED IN 168 AND IN 71 OF CASES, RESPECTIVELY. THE REPORTED COMPLICATIONS INCLUDED GRANULOMA (N=9), INFECTION (N=1), DEHISCENCE (N=5), AND FOCAL RIM TENDERNESS (N=6). IN CONCLUSION, COMPLICATIONS IN BOTH GROUPS WERE MINIMAL, SIMILAR TO PRIOR STUDIES, AND THERE WAS NO DIFFERENCE BETWEEN THE 2 COHORTS. WHILE IT HAS BEEN SUGGESTED THAT BURIED CONJUNCTIVA MAY RESULT IN INCREASED COMPLICATION RATES, THE AUTHOR¿S FINDINGS SUGGEST THAT REMOVING THE TARSAL CONJUNCTIVA IS A SUPERFLUOUS STEP IN THE LATERAL TARSAL STRIP SURGERY AND DOES NOT AFFECT COMPLICATION RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2240425 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention