BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 21941427 · Received May 1, 2025

    Report

    Report Number
    2210968-2025-04777
    Event Type
    Injury
    Date Received
    May 1, 2025
    Date of Event
    October 31, 2023
    Report Date
    May 1, 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
    ID
    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: RUSMAYANI E, VIONA V, SOEBIJIANTORO I, ET AL, EARLY EXPERIENCE WITH THE NOVEL GLAUCOMA SHUNT DEVICE: PAUL GALUCOMA IMPLANT IN THE INDONESIAN POPULATIONS. GUOII YANKE ZAZHI (INT EVE SCI) 2023, 23 (10): 1603 - 160. HTTPS://DOI.ORG/10.3980/J.ISSN.1672-5123.2023.10.01.

    Description of Event or Problem · 0

    TITLE: EARLY EXPERIENCE WITH THE NOVEL GLAUCOMA SHUNT DEVICE : PAUL GLAUCOMA IMPLANT IN THE INDONESIAN POPULATION. THE AIM OF THIS STUDY IS TO INVESTIGATE THE SAFETY AND EFFICACY OF PAUL GLAUCOMA IMPLANT (PGI) IN THE SHORT - TERM FOLLOW-UP PERIOD AND SHARE FIRST EXPERIENCE WITH THIS NOVEL AQUEOUS SHUNT IN INDONESIAN POPULATIONS. BETWEEN APRIL 2022 TO DECEMBER 2022, A TOTAL OF 21 PATIENTS (22 EYES) WITH AT LEAST A COMPLETE 2 - MONTH FOLLOW - UP. VYCRIL SUTURE (7-0, 8-0;ETHICON) IS USED FOR CORNEAL TRACTION TO ROTATE THE EYE INTO DOWN GAZE AND ALSO USED TO CLOSED THE CONJUNCTIVA. ETHILON SUTURE (8-0, ;ETHICON) IS USED TO SUTURE THE SCLERA. PROLENE STENT (7-0,; ETHICON) IS INSERTED INTO THE TUBE TO PREVENT EARLY HYPOTONY. REPORTED COMPLICATIONS ARE: VYCRIL SUTURE (7-0, 8-0; ETHICON) -DIPLOPIA (N=2) TREATMENT: NOT PROVIDED. - EARLY HYPOTONY DUE TO TRACTION OF THE PROLENE SUTURE (N=1) TREATMENT: NOT PROVIDED, BUT ABLE TO BE RESOLVED IN 2 WK POST-OP FOLLOW-UP PERIOD. -HYPHEMA (N=1) TREATMENT: NOT PROVIDED, BUT RESOLVE WITHIN 3WK -EXPOSED TUBE (N=2) TREATMENT: NEEDED TO BE REVISED IN THE OPERATING THEATRE ETHILON SUTURE (8-0, ETHICON). -DIPLOPIA (N=2) TREATMENT: NOT PROVIDED. - EARLY HYPOTONY DUE TO TRACTION OF THE PROLENE SUTURE (N=1) TREATMENT: NOT PROVIDED, BUT ABLE TO BE RESOLVED IN 2 WK POST-OP FOLLOW-UP PERIOD -HYPHEMA (N=1) TREATMENT: NOT PROVIDED BUT RESOLVE WITHIN 3WK. -EXPOSED TUBE (N=2) TREATMENT: NEEDED TO BE REVISED IN THE OPERATING THEATRE PROLENE STENT (7-0, ETHICON). -DIPLOPIA (N=2) TREATMENT: NOT PROVIDED - EARLY HYPOTONY DUE TO TRACTION OF THE PROLENE SUTURE (N=1) TREATMENT: NOT PROVIDED, BUT ABLE TO BE RESOLVED IN 2 WK POST-OP FOLLOW-UP PERIOD. -HYPHEMA (N=1) TREATMENT: NOT PROVIDED, BUT RESOLVE WITHIN 3WK -EXPOSED TUBE (N=2) TREATMENT: NEEDED TO BE REVISED IN THE OPERATING THEATRE. IN CONCLUSION, PGI IS A NOVEL GLAUCOMA TUBE SHUNT AND IS EFFECTIVE FOR LOWERING IOP. THE COMPLETE SUCCESS OF THE PGI TUBE IN THIS STUDY WAS 59 % WITH NO SERIOUS POSTOPERATIVE COMPLICATIONS FOUND IN OUR CASES. ONE CASE OF HYPOTONY RESOLVED IN THE EARLY POSTOPERATIVE PERIOD. THE SURGICAL METHOD OF USING A 7/0 PROLENE STENT IS SAFE AND EFFECTIVE IN PREVENTING EARLY HYPOTONY. FURTHER STUDIES WITH LONGER DURATION OF FOLLOW - UPS ARE REQUIRED TO ASSESS THE SAFETY AND EFFICACY OF THE PGI IN THE INDONESIAN POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071709 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention