BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BLK 30IN 5-0 S/A RB-1

    MDR report key: 14915438 · Received July 5, 2022

    Report

    Report Number
    2210968-2022-05096
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    January 1, 2022
    Report Date
    July 5, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    10705031044548
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: PLEASE CONFIRM THE PACKAGING ALREADY HAD ANY TEARS/HOLES IN THE STERILE PACKAGING: IF YES, HOW MANY PACKAGING HAD THIS ISSUE? WAS THE STERILITY OF THE DEVICE COMPROMISED? PLEASE DESCRIBE THE STERILE PACKAGING: WERE THERE ANY ISSUES WITH THE SEAL OF THE STERILE PACKAGING? PLEASE PROVIDE THE LOT NUMBER: PACKAGE ALREADY HAD TEARS IN IT. THERE WAS NO ISSUE WITH STERILITY OR STERILE PACKAGING. UNKNOWN TO THE REST OF QUESTIONS. EVENTS REPORTED VIA: 2210968-2022-05091, 2210968-2022-05092, 2210968-2022-05093, 2210968-2022-05094, 2210968-2022-05095 AND 2210968-2022-05096.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE PACKAGING OF THIS PRODUCT WOULD JUST WEAR AND TEAR FROM SITTING ON THE SHELF. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. SIX DEVICES WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422092 SILK BLK 30IN 5-0 S/A RB-1 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. K870H 10705031044548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown