BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLA PROLENE 15CM X 15CM

    MDR report key: 16715603 · Received April 11, 2023

    Report

    Report Number
    2210968-2023-02623
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    January 1, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS ANY HARM CAUSED TO THE PATIENT AS A RESULT OF USING THE SUSPECT PRODUCT?: NO HARM WAS CAUSED TO THE PATIENT. DO WE HAVE THE DETAILS OF THE COMPLAINANT? YES DOCTOR PERCEIVED THAT IT WAS COUNTERFEIT. DO WE HAVE IMAGES OF THE PRODUCT IN QUESTION OR HAVE POSSESSION OF THE PRODUCT ITSELF?: ALREADY SENT YOU THE IMAGE BUT MESH HAS BEEN USED TO THAT PATIENT. DO WE KNOW IF THE PRODUCT WAS FROM THE HOSPITAL¿S SUPPLY CHAIN OR PURCHASE INDEPENDENTLY BY THE PATIENT?: I SUPPOSE THIS PRODUCT WAS FROM HOSPITAL SUPPLY. WAS THERE ANY PATIENT CONSEQUENCE? NO THERE WAS NO PATIENT CONSEQUENCE. WAS THE DEVICE REMOVED? IF YES PLEASE DATE AND DETAILS OF THE RE-OPERATION. IF NO, ARE THERE ANY FUTURE INTERVENTIONS PLANNED? DEVICE WAS NOT REMOVED AND AS PER DOCTOR THE PATIENT IS FINE. HOW WAS THE PRODUCT PURCHASED? THE PRODUCT WAS PURCHASED THROUGH INTERNAL HOSPITAL PURCHASE. IS THERE AN INDICATION OF HOW THE PRODUCT WAS DISTRIBUTED? THROUGH PURCHASE OF EXTERNAL. IS THERE ANY INDICATION OF THE SOURCE? THE SOURCE IS LIKE GOVT HOSPITAL (B)(6) BUYS THROUGH DHS (B)(6) OR THROUGH LOCAL PURCHASE OR THROUGH HOSPITAL TRANSFER OF DISTRICT HOSPITALS. PHOTO ANALYSIS SUMMARY: A PHOTO WAS SENT TO ETHICON FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED. VISUAL ANALYSIS OF THE IMAGE REVEALED THAT A SAMPLE WAS RECEIVED BELONGING TO PRODUCT CODE PMM1. THE IMAGE WAS VISUALLY INSPECTED PRODUCT CODE PMM1 AND LOT V0004. UPON VISUAL INSPECTION, MULTIPLE LABELING DISCREPANCIES WERE IDENTIFIED, FOR EXAMPLE THE PRINTED INFORMATION WAS PLACED IN AN INCORRECT LOCATION. IN ADDITION, THE WRITING STYLE AND FONT OF THE PRODUCT ILLUSTRATION DID NOT MATCH THE INFORMATION ON FILE. BASED ON THE SAMPLES RECEIVED, THE PRODUCT IS CONFIRMED TO BE COUNTERFEIT DUE TO THE DISCREPANCIES FOUND IN THE LABELING AND PACKAGING MATERIAL. AS PART OF POST-MARKET SURVEILLANCE, ADDITIONAL MONITORING OF CLAIMS INFORMATION WILL BE CONDUCTED TO DETECT POTENTIAL SAFETY SIGNALS. TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. H6 COMPONENT CODE: G07002. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR PROCEDURE IN (B)(6) 2023 AND MESH WAS USED. THE DOCTOR FOUND OUT THAT MESH IS COUNTERFEIT AND IS SOFT MANY A TIMES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861836 MALLA PROLENE 15CM X 15CM MESH, SURGICAL, POLYMERIC FTL ETHICON INC. V1004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown