BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERCEED (TC7)7.6 CM X 10.2 CM

    MDR report key: 12140526 · Received July 8, 2021

    Report

    Report Number
    2210968-2021-06162
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 8, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    MCN
    PMA / PMN Number
    P880047
    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: 07/29/2021. ADDITIONAL INFORMATION: H6. H3 EVALUATION: VISUAL ANALYSIS OF THE SEVEN PICTURES WERE RECEIVED FOR EVALUATION AND SHOWED ONE OPENED BOX OF PRODUCT AND ONE FOIL PACKET OF PRODUCT WITH A DIFFERENT LOT NUMBER AND MANUFACTURE/EXPIRATION DATES. ACCORDING TO THE MANUFACTURE DATES, THERE IS A SEVEN MONTH DIFFERENCE BETWEEN BOTH LOTS OF PRODUCTS. DUE TO THE DIFFERENCE IN DATES, IT IS NOT POSSIBLE THAT IT WAS MIXED DURING THE MANUFACTURING PROCESS. DURING THE PACKAGING PROCESS, EACH BOX AND LABEL BARCODE IS SCANNED INTO THE SYSTEM TO COMPARE THE INFORMATION. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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 Manufacturer Narrative · 1

    (B)(4). DEVICE BOX LABELED AS M4350 WITH THE LOT 3936510. DEVICE PACKAGE LABELED AS M4350 WITH THE LOT 3935778. "A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA FOR LOT 3935778 AND PRODUCT CODE M4350. EXPIRATION DATE : 30.APR.2024; MANUFACTURING DATE : 05.MAY.2019". TO DATE THE DEVICE HAS NOT BEEN RETURNED. PHOTOS OF THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOSPITAL STAFF UNDERWENT A ROUTINE INVENTORY CHECK ON (B)(6) 2021 AND THE ADHESION BARRIER WAS INVOLVED. IT WAS REPORTED THAT THE LOT NUMBER ON THE DEVICE BOX LABEL WAS INCONSISTENT WITH THE LOT NUMBER ON THE LABEL FOR THE PACKAGES IN THE BOX. THE PRODUCTS WERE NOT INVOLVED IN ANY SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036713 INTERCEED (TC7)7.6 CM X 10.2 CM BARRIER, ABSORBABLE, ADHESION MCN ETHICON INC. 3936510

    Patients

    Seq Age Sex Outcome Treatment
    1