BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 21354988 · Received February 11, 2025

    Report

    Report Number
    2210968-2025-01538
    Event Type
    Injury
    Date Received
    February 11, 2025
    Date of Event
    May 15, 2024
    Report Date
    February 11, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: J. CLIN. MED. 2024, 13, 2914. HTTPS://DOI.ORG/10.3390/JCM13102914.

    Description of Event or Problem · 0

    TITLE: PAUL GLAUCOMA IMPLANT FOLLOWING CONGENITAL CATARACT SURGERY IN A PEDIATRIC COHORT. THE RETROSPECTIVE, SINGLE-CENTER STUDY AIMED TO REPORT THE SHORT-TERM SAFETY AND EFFECTIVENESS OF PGI FOR GLAUCOMA FOLLOWING CONGENITAL CATARACT SURGERY IN A PEDIATRIC COHORT, AS THIS HAS NOT BEEN PREVIOUSLY REPORTED. TEN EYES DIAGNOSED WITH GLAUCOMA FOLLOWING CONGENITAL CATARACT SURGERY UNDERWENT PAUL GLAUCOMA IMPLANTATION FROM JULY 2022 TO NOVEMBER 2023. THE MEAN AGE WAS 13.10 ± 3.64, YEARS AND THE MAJORITY OF THE POPULATION WAS MALE (70.0%). THE MEAN FOLLOW-UP TIME WAS 7.70 ± 4.22 MONTHS (RANGE, 4.68¿10.72 MONTHS).ONLY TWO EYES HAD 12 MONTHS OF FOLLOW-UP. REPORTED COMPLICATIONS INCLUDED (N=1) ONE PATIENT WITH AN IOP 29 MMHG WITH TWO ANTIGLAUCOMA MEDICATION. IN CONCLUSION, PGI IMPLANTATION SIGNIFICANTLY LOWERED IOP AND THE NUMBER OF ANTIGLAUCOMA EYE DROPS WITH A FAVORABLE SAFETY PROFILE IN CHILDREN DIAGNOSED WITH GFCS, THEREBY ACHIEVING A HIGH RATE OF QUALIFIED SURGICAL SUCCESS IN THE SHORT TERM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657735 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention