BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE UNKNOWN

    MDR report key: 22923493 · Received August 29, 2025

    Report

    Report Number
    2210968-2025-09988
    Event Type
    Injury
    Date Received
    August 29, 2025
    Report Date
    September 30, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. IF IN YOUR POSSESSION, MAY WE HAVE A COPY OF YOUR OPERATIVE REPORT? DOES ETHICON HAVE YOUR PERMISSION TO CONTACT YOUR SURGEON, IN THE EVENT ETHICON WOULD LIKE TO CONTACT YOUR SURGEON FOR MORE CLINICAL INFORMATION TO BE USED FOR A PRODUCT QUALITY COMPLAINT INVESTIGATION? IF SO, PLEASE PROVIDE THE FOLLOWING INFORMATION ON THE AUTHORIZATION TO USE OR DISCLOSE INFORMATION FORM ATTACHED: YOUR SURGEON¿S NAME, EMAIL, PHONE NUMBER, ADDRESS YOUR SIGNATURE PLEASE SCAN THE SIGNED FORM AND EMAIL BACK TO ETHICON.

    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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: SO, I HAVE MY SURGEONS REPORT IN FRONT OF ME AND THE OPERATION THEY USED TWO OUT OF THE THREE SUTURES. SUTURE CHRONIC GUT 6¿0 G ¿ 1 790 G. SUTURE ETHIBOND 2¿0 TIES 185H. AND THE THIRD ONE IS ON MY REPORT, BUT THE DOCTOR SAID HE DIDN¿T USE IT EVEN THOUGH IT¿S ON MY REPORT HE SAID IT WAS OPENED, BUT HE DIDN¿T USE IT AND THAT WOULD BE. SUTURE ETHELON 5¿0 RD-ONE 749G.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT AN EYE SURGERY FOR A DETACHED RETINA ON (B)(6) 2022 AND SUTURE WAS USED. THE PATIENT STATED THEY FELT A POKE THROUGH THE WHITE OF THE EYE IN THREE DIFFERENT AREAS. THE PATIENT LATER CLARIFIED THEY DID NOT FEEL A ¿POKE¿ IN THE EYE AND THAT THE SUTURE ACTUALLY CAME THROUGH THE WHITE OF THE EYE. THE PATIENT HAD SURGERIES FOR SUTURE REMOVAL IN (B)(6) 2023 FOR ONE SUTURE AND AN ADDITIONAL 3 SUTURES IN (B)(6) 2024 CAME THROUGH IN THE FORM OF CYSTS. THE PATIENT STARTED OXERVATE ON AUGUST 8 FOR PAIN. THE PATIENT STATED THAT THIS HAS BEEN ONGOING FOR THREE YEARS AND HAD 30 ADDITIONAL DOCTORS TRYING TO FIGURE IT OUT. THE PATIENT¿S OPINION WAS THAT THE SUTURE DID NOT DISSOLVE THE WAY IT WAS SUPPOSED TO. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163298 SUTURE UNKNOWN SUTURE, ABSORBABLE GAK ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention