BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE SUTURE 36"(90CM) 5-0 BLU

    MDR report key: 11914422 · Received June 1, 2021

    Report

    Report Number
    2210968-2021-05092
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    January 1, 2021
    Report Date
    May 7, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031045729
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4) DATE SENT TO THE FDA: 07/02/2021 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, 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: H6, H4, D4 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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: WHAT WAS THE NAME OF THE PROCEDURE? I DO NOT HAVE ANY MORE INFORMATION. WHAT WAS THE PROCEDURE DATE? I DO NOT HAVE ANY MORE INFORMATION. DID THE SUTURE BREAK OR DID THE SUTURE SEPARATED FROM THE NEEDLE? I DO NOT HAVE ANY MORE INFORMATION. IN RELATION TO NEEDLE, WHAT IS THE APPROXIMATE LOCATION OF SUTURE BREAKAGE? I DO NOT HAVE ANY MORE INFORMATION. DID THE SUTURE SEPARATE COMPLETELY? I DO NOT HAVE ANY MORE INFORMATION. WHAT TISSUE WAS BEING APPROXIMATED OR SUTURED WHEN IT BROKE? I DO NOT HAVE ANY MORE INFORMATION. EVENTS REPORTED IN 2210968-2021-05093.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2021 AND SUTURES WERE USED. DURING THE PROCEDURE, TWO SUTURES BROKE WITHOUT TENSION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808594 PROLENE SUTURE 36"(90CM) 5-0 BLU SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. M8556 QPBDCP 10705031045729

    Patients

    Seq Age Sex Outcome Treatment
    1