BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ UD 18IN 5-0 S/A P-3 PRM MP

    MDR report key: 16473557 · Received March 2, 2023

    Report

    Report Number
    2210968-2023-01438
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    February 2, 2023
    Report Date
    April 14, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031053663
    PMA / PMN Number
    K032420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS THERE ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE PATIENT? IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY SEVERAL TIMES. WHAT IS THE TOTAL NUMBER OF PRODUCTS INVOLVED IN THIS EVENT? WHEN WAS THE NEEDLE DETACHED/PULLED OFF FROM THE SUTURE (IN THE PACKAGE, DURING REMOVAL FROM PACKAGE, DURING HANDLING PRIOR TO USE ON PATIENT OR DURING USE ON THE PATIENT)? PLEASE SPECIFY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. EVENTS REPORTED ON MW# 2210968-2023-01439. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. TRADE NAME - IRGACARE®, ACTIVE INGREDIENT(S) ¿ TRICLOSAN, DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL, STRENGTH ¿ = 275 G/M VICRYL. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, 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 Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 3/27/2023. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, 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. THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED, BUT UNAVAILABLE: - WAS THERE ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE PATIENT? --SURGERY TIME PROLONGED FOR UNKNOWN TIME. - IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY SEVERAL TIMES. WHAT IS THE TOTAL NUMBER OF PRODUCTS INVOLVED IN THIS EVENT? --CONTACTED WITH THE SALES REP TODAY VIA PHONE AND THE INFORMATION REQUESTED IS UNKNOWN. - WHEN WAS THE NEEDLE DETACHED/PULLED OFF FROM THE SUTURE (IN THE PACKAGE, DURING REMOVAL FROM PACKAGE, DURING HANDLING PRIOR TO USE ON PATIENT OR DURING USE ON THE PATIENT)? PLEASE SPECIFY --CONTACTED WITH THE SALES REP TODAY VIA PHONE AND THE INFORMATION REQUESTED IS UNKNOWN. RELATED REPORTS: 2210968-2023-01438, 2210968-2023-01439.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). DATE SENT TO THE FDA: 4/14/2023 THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, 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 THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: AFTER INVESTIGATION, THE PATIENT UNDERWENT SECONDARY EAR DEFORMITY RECONSTRUCTION ON (B)(6) 2023. THE SURGEON USED VCP493H FOR SUBCUTANEOUS AND SKIN TISSUE SUTURING DURING THE OPERATION. DURING THE SUTURING, THE NEEDLE PULL OFF OCCURRED AND FELL INTO THE PATIENT'S TISSUE. THE SURGEON IMMEDIATELY GAVE THE PATIENT INTRAOPERATIVE X-RAY EXAMINATION TO ASSIST IN LOOKING FOR THE NEEDLE AND FOUND IT. AFTER REMOVAL, THE INTEGRITY OF THE NEEDLE WAS CHECKED. AFTER CONFIRMING THAT THERE WAS NO RESIDUAL FOREIGN BODY IN THE PATIENT'S TISSUE, A NEW SUTURE (WITH UNKNOWN SPECIFIC PRODUCT INFORMATION) WAS REPLACED FOR SUTURING. THE SUBSEQUENT SURGICAL OPERATION WENT SMOOTHLY. THE EVENT DID NOT CAUSE HARM TO THE PATIENT EXCEPT FOR PROLONGED OPERATION TIME (SPECIFIC EXTENSION TIME WAS UNKNOWN). THE PATIENT HAS BEEN DISCHARGED CURRENTLY. RELATED REPORTS: 2210968-2023-01438, MW# 2210968-2023-01439.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT WOUND CLOSURE ON (B)(6) 2023 AND SUTURE WAS USED. PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516101 VCL+ UD 18IN 5-0 S/A P-3 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP493H SCMLCL 10705031053663

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male