BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCL CT BRD VIO 12IN 8-0 S/A GS-9

    MDR report key: 19086384 · Received April 11, 2024

    Report

    Report Number
    2210968-2024-04190
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    January 1, 2023
    Report Date
    April 11, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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. 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. CITATION: KLIN MONATSBL AUGENHEILKD 2023; 240:391-393. HTTPS://DOI.ORG/10.1055/A-2004-5330.

    Description of Event or Problem · 0

    TITLE: CONJUNCTIVAL FOREIGN BODY GRANULOMA AFTER PTERYGIUM EXCISION AND ADAPTATION BY POLYGLACTIN SUTURES. THIS STUDY REPORTS A CASE OF A 58-YEAR-OLD FEMALE PATIENT WHO UNDERWENT SURGICAL REMOVAL OF A PTERYGIUM ON THE NASAL SDE OF HER LEFT EYE (OS) AFTER A 4-YEAR HISTORY OF FREQUENT ITCHING, PAIN, AND OCCASIONAL CONJUNCTIVAL CONGESTION. AFTER TOPICAL AND SUBCONJUNCTIVAL ANAESTHESIA (TETRACAINE SDU FAURE 1%, THÉA PHARMA, SCHAFFHAUSEN, SWITZERLAND AND LIDOCAIN STREULI 1%, STREULI, UZNACH, SWITZERLAND), THE HEAD OF THE PTERYGIUM WAS UNDERMINED AND REMOVED BY BLUNT DISSECTION, THEN THE TAIL WAS EXCISED. THE CORNEAL SURFACE WAS POLISHED WITH A DIAMOND DUSTED DENTAL BUR. THE CONJUNCTIVA WAS UNDERMINED AND PRIMARILY ADAPTED WITH COATED 8¿0 POLYGLACTIC (VICRYL V120G, ETHICON, NEUCHÂTEL, SWITZERLAND) INTERRUPTED SUTURES. REPORTED COMPLICATIONS INCLUDE CONJUNCTIVAL DEHISCENCE AT THE LIMBAL SIDE OCCURRED AT 26 DAYS AFTER PRIMARY SURGERY WHICH WAS CLOSED BY 3 ADDITIONAL INTERRUPTED 8¿0 POLYGLACTIC SUTURES. NASAL CORNEAL ¿DELLEN¿ AND A FLAT SUBCONJUNCTIVAL HAEMORRHAGE PRESENTED ON DAY 2 AFTER REVISION SURGERY. POSTOPERATIVE LOCAL TREATMENT CONSISTED OF OFLOXACIN, CARBOMER (LIPOSIC GEL, BAUSCH & LOMB, ZUG, SWITZERLAND) EYE DROPS, AND CARMELLOSE GEL (OPTAVA, ALLERGAN, CHAM, SWITZERLAND), WITHOUT LOCAL CORTICOSTEROIDS DUE TO THE SLOW REGRESSION OF CORNEAL ¿DELLEN¿. DURING FOLLOW-UP, THE NASAL CONJUNCTIVA PRESENTED PERSISTENT SWELLING, PROTRUSION, AND PROGRESSIVELY DEVELOPED GRANULATION TISSUE CLOSE TO THE LIMBUS (FIG. 1A). A SECOND REVISION WAS PERFORMED 50 DAYS AFTER PRIMARY PTERYGIUM EXCISION. PROLIFERATIVE TISSUE WAS RESECTED AND A FREE CONJUNCTIVAL GRAFT FROM THE TEMPORAL SUPERIOR CONJUNCTIVA OF THE SAME EYE WAS STABILISED BY 10¿0 NYLON SUTURES (ETHILON, ETHICON, NEUCHÂTEL, SWITZERLAND) IN THE NASAL POSITION. PATHOHISTOLOGICAL ANALYSIS OF THE RESECTED 3-MM SPECIMEN PRESENTED TYPICAL FINDINGS OF FOREIGN BODY GRANULOMA WITH GIANT MULTINUCLEAR AND MULTIPLE INFLAMMATORY CELLS AROUND THE POSITION OF PREEXISTING SUTURES (FIG. 2). POSTOPERATIVELY, HALF OF THE NYLON SUTURES WERE REMOVED AFTER 1 WEEK AND ALL REMAINING MATERIAL AFTER 2 WEEKS (FIG. 1B). FURTHER FOLLOW-UP AFTER THE THIRD INTERVENTION WAS UNEVENTFUL WITH FAVOURABLE STRUCTURAL AND FUNCTIONAL OUTCOMES UNTIL THE FINAL EXAMINATION 20 WEEKS AFTER THE LAST INTERVENTION. IN CONCLUSION, THE OCCASIONAL OBSERVATION OF CONJUNCTIVAL REACTIONS AFTER ADAPTATION OF THE CONJUNCTIVA BY VICRYL SUTURES IS A CLINICAL OBSERVATION WE SHARE, AND IT SEEMS THAT THESE REACTIONS DESERVE MORE ATTENTION AND SHOULD BE VERIFIED MORE OFTEN BY HISTOPATHOLOGICAL ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333914 VCL CT BRD VIO 12IN 8-0 S/A GS-9 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention