BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 18363940 · Received December 20, 2023

    Report

    Report Number
    2210968-2023-09938
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 9, 2023
    Report Date
    December 20, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: DID THE ISSUE "ALL SUTURES PLACED IN SURGICAL SITE RUPTURED" OCCUR DURING SURGERY OR AFTER SURGERY (POST-OP TREATMENT)? IF POST-OP, WAS WOUND DEHISCENCE OBSERVED? WERE THERE ANY PATIENT CONSEQUENCES? WHAT IS THE PROCEDURE NAME? CAN YOU IDENTIFY THE PRODUCT CODE AND LOT NUMBER OF THE PRODUCT THAT WAS USED? PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF THE EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP). EVENTS REPORTED VIA: 2210968-2023-09936,2210968-2023-09937.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT ALL SUTURES PLACED IN SURGICAL SITE RUPTURED NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957795 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown