BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL RAP UND1/5-0 45CM 1A.P1

    MDR report key: 12473761 · Received September 15, 2021

    Report

    Report Number
    2210968-2021-08441
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 9, 2021
    Report Date
    August 20, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) DATE SENT TO THE FDA: 11/3/2021 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. PLEASE CLARIFY IF THERE WERE ANY ADVERSE PATIENT CONSEQUENCES DUE TO THIS EVENT? IF YES, PLEASE EXPLAIN IN DETAIL: UNK 2. PLEASE EXPLAIN IN DETAIL WHAT DO YOU MEAN BY "IT HAD SOME INFLUENCE ON THE OPERATION PROCESS". IN WHICH WAY DOES THIS EVENT INFLUENCE THE OPERATION PROCESS?: THE FAILURE OF THE DEVICE FAILED TO FUNCTION AS EXPECTED, BUT THE OPERATION WENT WELL AFTER CHANGING ANOTHER DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. PLEASE CLARIFY IF THERE WERE ANY ADVERSE PATIENT CONSEQUENCES DUE TO THIS EVENT? IF YES, PLEASE EXPLAIN IN DETAIL PLEASE EXPLAIN IN DETAIL WHAT DO YOU MEAN BY "IT HAD SOME INFLUENCE ON THE OPERATION PROCESS". IN WHICH WAY DOES THIS EVENT INFLUENCE THE OPERATION PROCESS? A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIGH LIGATION FOR A RIGHT HYDROCELE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372182 VICRYL RAP UND1/5-0 45CM 1A.P1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. AN6087

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR