BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICEL* 10X20CM

    MDR report key: 19085056 · Received April 10, 2024

    Report

    Report Number
    2210968-2024-04185
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    February 13, 2024
    Report Date
    April 10, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: ¿IS THERE ANY INDICATION OF THE SOURCE? NO. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: ¿HOW WAS THE PRODUCT PURCHASED? ¿IS THERE AN INDICATION OF HOW THE PRODUCT WAS DISTRIBUTED? ¿BASED ON THE PACKAGING, IS THERE ANY INDICATION OF WHICH MARKET THE ORIGINAL GENUINE PRODUCT MAY HAVE COME FROM? ¿WAS THE DEVICE USED ON A PATIENT? IF SO, WAS THERE ANY PATIENT CONSEQUENCE? INVESTIGATION SUMMARY. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT IT WAS RECEIVED ONE UNOPENED SAMPLE THAT PERTAIN TO PRODUCT CODE 1902GB. AN ANALYSIS WAS PERFORMED ON THE RETURNED SAMPLE BY DOING A COMPARISON WITH ARTWORK FILE LAB-0012767 REV 2 AND SEVERAL DIFFERENCES WERE FOUND. 1.- THE FONTS ARE NOT MATCHING. 2.- THE BARCODE NUMBER DOES NOT MATCH. 3.- EASY PEEL SYMBOLS SHIFTED ON THE LEFT SIDE. 4.- NO LINE STAMP ON THE BACK OF THE POUCH. 5.- THE LOT NUMBER PRINTED 3935581 IS NOT THE SAME LOT NUMBER THAT THE ONE IN THE 2D BAR CODE 3928544. 6.- THE QUALITY OF THE POUCH IS POOR COMPARED WITH THE ONE OF ETHICON. 7.- THE QUALITY OF THE PRODUCT IS POOR BY DOING A COMPARISON WITH A SURGICEL PRODUCED AT ETHICON. THEREFORE, BASED ON THE INVESTIGATION, THE COMPLAINT IS CONFIRMED AS A COUNTERFEIT PRODUCT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TRAINING WAS CARRIED OUT IN THE NEUROSURGERY SERVICE OF THE HOSPITAL, ON THE ABSORBABLE HEMOSTAT. WHILE EXPLAINING THE CHARACTERISTICS AND BENEFITS OF THE PRODUCT, ONE DOCTOR, HEAD OF THE SERVICE, AND ANOTHER DOCTOR, R4 OF THE SERVICE, INFORMED HIM THAT THEY ALREADY WORK WITH ABSORBABLE HEMOSTAT, WHICH IS A PRODUCT THAT DOES NOT PROVIDE HEMOSTASIS AND FRAYS. AT THAT TIME THEY TOOK OUT A ABSORBABLE HEMOSTAT THAT A PATIENT HAD GIVEN THEM FOR HIS SURGERY AND SHOWED IT TO THE SALES REPRESENTATIVE. THE DOCTORS SAY THAT ALL PATIENTS BUY IT AT FARMA SOLUCION IN FRONT OF THE HOSPITAL. THE PRODUCT IS NOT AN APPROVED CODE (WITH SANITARY REGISTRY) IN PERU, SO IT HAS NOT BEEN IMPORTED BY JNJ. ITS ENTRY INTO THE COUNTRY IS NOT REGULAR, THEREFORE THE MARKETING OF THIS PRODUCT IS PROHIBITED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800635 SURGICEL* 10X20CM AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC. 3935581

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown