BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICEL ORIGINAL 4INX8IN(10.2CMX20.3CM)

    MDR report key: 21938338 · Received April 30, 2025

    Report

    Report Number
    2210968-2025-04754
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    March 31, 2025
    Report Date
    April 30, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    UDI-DI
    10705031468115
    PMA / PMN Number
    N12159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. H6. INVESTIGATION FINDINGS: C22 ¿ PHOTO EVALUATION. H6. MEDICAL DEVICE PROBLEM CODE - A27 ¿ DIVERSION. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: BASED ON THE PACKAGING, IS THERE ANY INDICATION OF WHICH MARKET THE ORIGINAL GENUINE PRODUCT MAY HAVE COME FROM? BATCH: UCB5111 WAS SOLD IN USA. BATCHES: 100PR9 AND 101D3 WERE SOLD IN BRAZIL, IT IS NOT DIVERSION. WAS THE DEVICE USED ON A PATIENT? IF SO, WAS THERE ANY PATIENT CONSEQUENCE? NO. HOW MANY DEVICES ARE SUSPECTED TO BE COUNTERFEIT? ONE BATCH ¿ UCB5111 ¿ LABEL IS COUNTERFEIT. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: HOW WAS THE PRODUCT PURCHASED? NA. IS THERE AN INDICATION OF HOW THE PRODUCT WAS DISTRIBUTED? NA. IS THERE ANY INDICATION OF THE SOURCE? NA. IS THE DEVICE AVAILABLE TO BE RETURNED FOR EVALUATION? IF SO, PLEASE PROVIDE THE STATUS OF THE RETURN SAMPLE AND ANY AVAILABLE TRACKING INFORMATION. NA. C22 PHOTO INVESTIGATION SUMMARY: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE IMAGE WAS VISUALLY INSPECTED PRODUCT CODE: 1952S AND LOT: UCB5111. UPON VISUAL INSPECTION, MULTIPLE LABELING DISCREPANCIES WERE IDENTIFIED, FOR EXAMPLE: INK IS SMUDGING ON THE POUCH AND YELLOW MARKING ON POUCH. CUSTOMER SUPPORT SERVICES PERFORMED A REVIEW OF THE PRODUCT TRACEABILITY INFORMATION AND THIS PRODUCT IS AUTHORIZED TO BE DISTRIBUTED WITHIN COLOMBIA BUT THE ACCOUNT THAT ACQUIRED THIS PRODUCT IS UNKNOWN. BASED ON THE INVESTIGATION PERFORMED, IT WAS DETERMINED THAT THE PRODUCT IS COUNTERFEIT, WAS CONFIRMED. ETHICON PRODUCTS WERE NOT DISTRIBUTED BY AUTHORIZED AFFILIATES. 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 MONITORING OF COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDS AS PART OF POST-MARKET SURVEILLANCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCE'S 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 UNAUTHORIZED DISTRIBUTORS SELLING ABSORBABLE HEMOSTAT IN MINAS GERAIS. ONE BATCH WAS NOT DISTRIBUTED IN BRAZIL; IT HAS A LABEL THAT IS NOT FROM J&J ¿ DEVIATION CONFIRMED WITH THE POSSIBILITY OF BEING FAKE. TWO OTHER BATCHES WERE SOLD IN BRAZIL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370592 SURGICEL ORIGINAL 4INX8IN(10.2CMX20.3CM) AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC. UCB5111 10705031468115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown