BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL RAP UND 45CM M1 USP5/0 SGLE ARMED P-1 PRIME

    MDR report key: 20778098 · Received November 26, 2024

    Report

    Report Number
    2210968-2024-12445
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    October 5, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031231078
    PMA / PMN Number
    K033746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED LATER A SUPPLEMENTAL MEDWATCH WILL BE SENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE FOLLOWING INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS RECEIVED: IS THE DEVICE AVAILABLE TO BE RETURNED FOR EVALUATION? NO. IS A PHOTO AVAILABLE OF THE PRODUCT? NO. PLEASE CONFIRM THE NUMBER OF SUTURES THAT BROKE DURING SUTURING. WAS THE DEVICE USED ON A PATIENT? IF SO, WAS THERE ANY PATIENT CONSEQUENCE? HOW WAS THE PRODUCT PURCHASED? IS THERE AN INDICATION OF HOW THE PRODUCT WAS DISTRIBUTED? IS THERE ANY INDICATION OF THE SOURCE? BASED ON THE PACKAGING, IS THERE ANY INDICATION OF WHICH THE ORIGINAL GENUINE PRODUCT MAY HAVE COME FROM? --CONTACT WITH THE SALES REP, PLEASE REFER TO THE EVENT DESCRIPTION AND TRACEABILITY RECORDS ATTACHED, OTHER INFORMATION REQUESTED IS UNKNOWN. THE FOLLOWING ADDITIONAL INFORMATION WAS REPORTED: THE PROCEDURE SHOULD BE DEBRIDEMENT AND SUTURE OF OPEN FRACTURE OF RIGHT INDEX FINGER. AFTER SALES REP VERIFIED THE COMPLAINT INFORMATION, IT WAS FOUND THE REPORTED DEVICES ARE SUSPECTED PRODUCTS. CHINA SUPPLY CHAIN AND ETHICON US EXPORT CUSTOMER SUPPORT SERVICES CHECKED PRODUCT TRACEABILITY INFORMATION, BUT NO RECORDS. EDC CHECKED AND FOUND THE PRODUCTS WERE MAINLY SHIPPED TO RDC AND TURKEY. RDC CHECKED AND FOUND THE PRODUCTS WERE MAINLY SHIPPED TO AUSTRALIA AND THAILAND. THE PRODUCT WAS USED BY HOSPITAL FOR SURGERY. ATTACHED TRACEABILITY REPORTS FROM EDC AND RDC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT DEBRIDEMENT AND SUTURE OF OPEN FRACTURE OF RIGHT INDEX FINGER ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE SUTURING PROCESS, THE SUTURE BROKE SEVERAL TIMES. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2434232 VICRYL RAP UND 45CM M1 USP5/0 SGLE ARMED P-1 PRIME SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. AU1241 10705031231078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown