BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD UD 27IN 4-0 S/A KS

    MDR report key: 14054356 · Received April 8, 2022

    Report

    Report Number
    2210968-2022-02520
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    February 17, 2022
    Report Date
    May 5, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031042070
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT NUMBER: (B)(4). (B)(4). 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: 1/19 C/S, 2/17 EDGES SLIGHTLY EVERTED, SOME STITCHES REMOVED, 2/24-INCISION HEALED. WHAT WAS THE PROCEDURE DATE? SEE ABOVE . WAS THERE ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE PATIENT? REQUIRED ADDITIONAL OFFICE VISITS FOR PATIENTS FOR WOUND CHECKS AND SUTURE REMOVAL AND CLEANING. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; DRAINAGE)? IF SO, PLEASE SPECIFY. SUTURES REMOVED. COULD YOU TELL ME IF THERE WAS A PRESCRIPTION FOR STEROIDS OR ANTIBIOTICS FOR THE PATIENT'S RECOVERY? IF YES, PLEASE PROVIDE MEDICATION NAME, ROUTE AND DOSE. NO MEDS PRESCRIBED. WHAT IS THE CURRENT STATUS OF THE PATIENT? INCISIONS NOW HEALED. WHAT IS THE LOT NUMBER? LOT QLMMTU, EXPIRES 9/30/2025.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 5/5/2022. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESARIAN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. ON (B)(6) 2022 EDGES SLIGHTLY EVERTED, SOME STITCHES REMOVED, 2/24-INCISION HEALED. IT WAS SUPPOSED TO BE AN ABSORBABLE SUTURE BUT IT WASN'T ABSORBING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282532 VCL CT BRD UD 27IN 4-0 S/A KS SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. J662H QLMMTU 10705031042070

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown