BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 20157333 · Received September 6, 2024

    Report

    Report Number
    2210968-2024-09350
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    January 1, 2024
    Report Date
    September 6, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    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. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS. VOLUME 122, SEPTEMBER 2024, 110168.

    Description of Event or Problem · 0

    TITLE: SEVERE CONJUNCTIVAL ALLERGIC REACTION TO POLYGLACTIN 910 SUTURES FOLLOWING STRABISMUS SURGERY: A CASE REPORT. AUTHOR'S: KHALID S. ALOTAIBI, ET AL. POLYGLACTIN 910 SUTURES ARE COMMONLY USED IN STRABISMUS SURGERY DUE TO THEIR FAVORABLE HANDLING AND ABSORPTION QUALITIES. HOWEVER, THEIR POTENTIAL TO CAUSE ALLERGIC REACTIONS IS POORLY DOCUMENTED IN MEDICAL LITERATURE. AN 11-YEAR-OLD GIRL WITH A HISTORY OF LEFT CONGENITAL PARTIAL THIRD NERVE PALSY WAS TREATED WITH 8¿ 0, POLYGLACTIN 910 SUTURES (ETHICON) DURING STRABISMUS SURGERY. THE REPORTED COMPLICATIONS INCLUDED: - 11-YEAR-OLD, FEMALE, (N=1) PERSISTENT REDNESS, SWELLING, AND PAIN IN HER LEFT EYE DESPITE ANTIBIOTIC THERAPY. AFTER SIX DAYS, THE SUTURES WERE REMOVED, RESULTING IN AN IMMEDIATE REDUCTION IN SYMPTOMS. IN CONCLUSION, HEALTHCARE PROVIDERS SHOULD BE ALERT TO POTENTIAL ALLERGIC REACTIONS TO SUTURES AFTER STRABISMUS SURGERY. TIMELY IDENTIFICATION AND REMOVAL ARE VITAL FOR RESOLVING THE SYMPTOMS AND ACHIEVING OPTIMAL PATIENT OUTCOMES. THIS CASE EMPHASIZES THE IMPORTANCE OF POSTOPERATIVE CARE PROTOCOLS THAT CONSIDER ALLERGIES TO SUTURE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035084 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention