BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 12651908 · Received October 18, 2021

    Report

    Report Number
    2210968-2021-09821
    Event Type
    Injury
    Date Received
    October 18, 2021
    Date of Event
    February 17, 2021
    Report Date
    October 18, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE, PROLENE SUTURE, NYLON SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS (HYPHEMA, FLAT CHAMBER / HYPOTONY, TUBE OR PLATE EXPOSURE, TUBE RETRACTION AND FAILED EYES) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE, PROLENE SUTURE, NYLON SUTURE) USED IN THIS STUDY? IF YES, PLEASE DESCRIBE. IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (HYPHEMA, FLAT CHAMBER / HYPOTONY, TUBE OR PLATE EXPOSURE, TUBE RETRACTION AND FAILED EYES)? WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION CITE: J. CLIN. MED. 2021, 10, 813. HTTPS://DOI.ORG/10.3390/JCM10040813. EVENTS WERE SUBMITTED VIA 2210968-2021-09822 AND 2210968-2021-09825.

    Description of Event or Problem · 0

    TITLE: OUTCOMES OF SMALL SIZE AHMED GLAUCOMA VALVE IMPLANTATION IN ASIAN CHRONIC ANGLE-CLOSURE GLAUCOMA. THIS RETROSPECTIVE REVIEW WAS CARRIED OUT AT A TERTIARY REFERRAL MEDICAL CENTER IN NORTHERN TAIWAN BETWEEN 2009 AND 2014. TOTAL OF 43 PATIENTS ENROLLED IN THIS STUDY, 24 PATIENTS WERE IN THE ANTERIOR CHAMBER (AC) GROUP AND THE OTHER 19 PATIENTS WERE IN THE POSTERIOR CHAMBER (PC) GROUP, WHICH WAS BASED ON THE PRESENCE OF ANTERIOR SYNECHIAE AT TUBE INSERTION SITE OR NOT. IN EACH CASE, A FORNIX-BASED CONJUNCTIVAL FLAP WAS CREATED IN THE SUPEROTEMPORAL OR SUPERONASAL QUADRANT BETWEEN TWO ADJACENT RECTI MUSCLES UNDER GENERAL ANESTHESIA. THE AGV (MODEL S3 OR FP-8, NEW WORLD MEDICAL, RANCHO (B)(4), CA, USA) WAS IRRIGATED WITH BALANCED SALINE SOLUTION (BSS, ALCON, (B)(4), USA) TO PRIME THE VALVE MECHANISM. THE PLATE WAS SOAKED WITH 0.4 MG/ML MITOMYCIN-C AND THEN WAS WIPED DRY 10 S LATER. AND IT WAS PLACED AT LEAST 7 MM POSTERIOR TO THE CORNEOSCLERAL LIMBUS AND FIXED FIRMLY TO THE SCLERA WITH 8-0 PROLENE SUTURES (ETHICON INC., (B)(4), USA). IN PC GROUP, THE TUBE WAS INSERTED TO CILIARY SULCUS (1.5 MM POSTERIOR TO THE LIMBUS) THROUGH A TRACT WHICH IS MADE BY 23 G NEEDLE WITHOUT SCLERECTOMY. IT IS NOT POSSIBLE TO PERFORM SCLERECTOMY IN PC GROUP DUE TO THE ANATOMICAL CONSIDERATION, WHICH CILIARY BODY COULD BE DAMAGED AFTER SCLERECTOMY. AFTER THE TUBE WAS INSERTED, THE SUPERFICIAL SCLERAL FLAP WAS CLOSED TIGHTLY WITH 10-0 NYLON SUTURES (ETHICON INC., (B)(4), USA). AND THE TUBE WAS SECURED WITH 8-0 PROLENE SUTURE. A HUMAN DONOR SCLERAL GRAFT WAS PLACED ON THE TUBE WITH THE ANTERIOR EDGE ADJACENT TO THE LIMBUS AND SUTURED TO THE SCLERA WITH AN 8-0 VICRYL SUTURE (ETHICON INC., (B)(4), USA). THE CONJUNCTIVA WAS THEN RE-APPROXIMATED WITH 8-0 VICRYL INTERRUPTED SUTURES. REPORTED COMPLICATIONS INCLUDED HYPHEMA (N=6), FLAT CHAMBER / HYPOTONY (N=2) TUBE OR PLATE EXPOSURE (N=3), TUBE RETRACTION (N=3), OF THE 7 FAILED EYES IN THE AC GROUP, 5 UNDERWENT SECOND AGV INSERTIONS, 1 UNDERWENT EVISCERATION OF THE EYEBALL AND 1 UNDERWENT A CYCLODESTRUCTIVE PROCEDURE. OF THE 7 FAILED EYES IN THE PC GROUP, 5 UNDERWENT SECOND AGV IMPLANTATIONS AND 2 UNDERWENT CYCLODESTRUCTIVE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549816 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention