BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 16103587 · Received January 5, 2023

    Report

    Report Number
    2210968-2023-00099
    Event Type
    Injury
    Date Received
    January 5, 2023
    Date of Event
    December 5, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED H6 CLINICAL CODE: E2402 ¿ PRESENT WIDE-ANGLE EXOTROPIA CITATION: HTTPS://DOI.ORG/10.37039/1982.8551.20220024

    Description of Event or Problem · 0

    TITLE: ACCESSORY MUSCLES AND STRABISMUS: CAUSE OR COINCIDENCE? A 32-YEAR-OLD MALE PATIENT WAS REFERRED TO THE UNIVERSITY HOSPITAL OF THE FEDERAL UNIVERSITY OF THE STATE OF RIO DE JANEIRO, REPORTING EXOTROPIA SINCE CHILDHOOD. HE REFUSED PREVIOUS TREATMENTS. FAMILY HISTORY, PAST PATHOLOGY, AND BIRTH HISTORY ARE NOT NOTABLE. ON EXAMINATION: STATIC REFRACTION RE 20/20 (+0.50 ESF.) AND LE 20/20 ABSENCE OF COMPENSATORY HEAD POSITION; CENTRAL FIXATION IN THE LE, WITH PREFERENCE FOR THE LE; MR BE MUSCLE HYPOFUNCTION (-2.00), WITH ABSENCE OF ANOMALOUS MOVEMENTS OR RETRACTION; EXOTROPIA OF 80 PD MEASURED BY THE ALTERNATING COVERAGE TEST IN PPG, WHICH REMAINED THE SAME IN THE OTHER POSITIONS; ABSENT STEREOPSIS AT EVALUATION (STEREOTEST); ANTERIOR AND POSTERIOR BIOMICROSCOPY AND TONOMETRY WITHOUT ALTERATIONS IN BE. THE DEVIATION REMAINED STABLE IN TWO CONSECUTIVE EVALUATIONS, 3 MONTHS APART, WHEN SURGICAL CORRECTION WAS PLANNED IN BE, WITH A 9MM RETRACTION OF THE LR MUSCLE AND 7MM RESECTION OF THE RM MUSCLE, BILATERALLY. IN THE PERI-OPERATIVE PERIOD, THE LEFT EYE PRESENTED A POSITIVE FDT ON ADDUCTION, WHICH REMAINED SLIGHTLY ALTERED EVEN AFTER RELEASING THE LR MUSCLE. BASED ON THE CORRECT DIAGNOSTIC SUSPICION AND CAREFUL EXPLORATION, STRIATED AND REDDISH FIBERS, WITH A TYPICAL MUSCULAR APPEARANCE, WERE FOUND 2 MM POSTERIOR TO THE INSERTION OF THE LR. THE AM WAS FOUND IN THE SAME PLANES AS THE ORIGINAL MUSCLE, WITH A VERTICAL LENGTH PROPORTIONAL TO ABOUT ONE THIRD OF IT, WITH FIBERS FACING IN THE SAME DIRECTION AND HEADING TOWARDS THE POSTERIOR DIRECTION OF THE GLOBE. THE CHARACTERISTIC TRAJECTORY MADE IT EASY TO DIFFERENTIATE FROM THE INFERIOR OBLIQUE MUSCLE . ITS INSERTION WAS 9.5MM FROM THE OCULAR LIMBUS, AND THE ORIGINAL LR WAS 7.5MM FROM IT. THE INTERMUSCULAR SEPTUM WAS NOT FOUND . THE CHOICE WAS MADE TO RELEASE THE AM, NEGATING THE FDT, ASSOCIATED WITH ITS SUTURE TO THE ORIGINAL LR WITH MERSILENE 5-0 THREAD ETHICON AND A 9MM RETRACTION OF THE LR OF THE RE. IN ADDITION TO THIS, 7MM RESECTIONS OF THE MEDIAL RECTUS MUSCLES BILATERALLY AND A 9MM RETRACTION OF THE LR MUSCLE OF THE RE WERE CARRIED OUT, AS PLANNED IN THE PRE-OPERATIVE PERIOD. AN INCISIONAL BIOPSY OF THE ACCESSORY TISSUE FOUND WAS ALSO CARRIED OUT. THE ANATOMOPATHOLOGICAL EXAMINATION IDENTIFIED STRIATED MUSCLE FIBERS, CONFIRMING THE PREVIOUS DIAGNOSIS. TWO MONTHS AFTER SURGERY, THE PATIENT HAD A MILD IMPROVEMENT IN THE CLINICAL PROFILE, MAINTAINING AN EXOTROPIA OF 50 PD IN THE PPG. HE IS STILL AWAITING SURGICAL REINTERVENTION TO RELEASE THE AM FROM THE GLOBE OR A NEW RETRACTION-RESECTION. REPORTED COMPLICATIONS INCLUDED PRESENT WIDE-ANGLE EXOTROPIA AND SCHEDULED SURGERY ASSOCIATED WITH THE SUTURE OF THE ACCESSORY MUSCLE TO THE LR MUSCLE. IN CONCLUSION , DESPITE THE IMPORTANCE OF IDENTIFYING ATYPICAL CASES LIKE THESE, UNSATISFACTORY SURGICAL RESULTS ARE POSSIBLE AND DIFFICULT TO PREDICT, SINCE THESE STRUCTURES CAN BE BOTH THE CAUSE OF STRABISMUS AND A SIMPLE INTRA-OPERATIVE FINDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723764 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Required Intervention