BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3DMAX LIGHT

    MDR report key: 24444420 · Received February 25, 2026

    Report

    Report Number
    1213643-2026-00212
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    February 3, 2026
    Report Date
    February 27, 2026
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741031038
    PMA / PMN Number
    K091659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, DURING ROUTINE INSPECTION AFTER RECEIVING THE GOODS, THE DISTRIBUTOR DISCOVERED UNKNOWN BLUE FILAMENTOUS SUBSTANCES INSIDE THE TRANSPARENT INNER PACKAGING OF THE PATCH. THE PHOTO PROVIDED AND PRELIMINARY EVALUATION OF THE SAMPLE CONFIRMS THE PRESENCE OF "FOREIGN" MATERIAL (THREAD LIKE, BLUE IN COLOR) INSIDE OF THE CLAMSHELL TRAY. FURTHER REVIEW OF THE RETURNED SAMPLE IS CURRENTLY ONGOING, AS SUCH NO CONCLUSIONS HAVE BEEN MADE. WHEN THE SAMPLE EVALUATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. REVIEW OF MANUFACTURING RECORDS CONFIRMS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    AS REPORTED, DURING ROUTINE INSPECTION AFTER RECEIVING THE GOODS, THE DISTRIBUTOR DISCOVERED UNKNOWN BLUE FILAMENTOUS SUBSTANCES INSIDE THE TRANSPARENT INNER PACKAGING OF THE PATCH. THE PHOTO PROVIDED AND PRELIMINARY EVALUATION OF THE SAMPLE CONFIRMS THE PRESENCE OF "FOREIGN" MATERIAL (THREAD LIKE, BLUE IN COLOR) INSIDE OF THE CLAMSHELL TRAY. FURTHER REVIEW OF THE RETURNED SAMPLE IS CURRENTLY ONGOING, AS SUCH NO CONCLUSIONS HAVE BEEN MADE. WHEN THE SAMPLE EVALUATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. REVIEW OF MANUFACTURING RECORDS CONFIRMS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. ADDENDUM: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED TO DOCUMENT THE SAMPLE EVALUATION RESULTS. THE RETURNED SAMPLE AND PHOTO ANALYSIS CONFIRMS THAT THERE IS "FOREIGN" MATERIAL (BLUE FILAMENT) IN THE CORNER OF THE CLAMSHELL TRAY. BASED ON SAMPLE AND MANUFACTURING PROCESS EVALUATION PERFORMED, THE IDENTIFIED CONDITION IS DETERMINED TO BE A MANUFACTURING-GENERATED CONDITION. A NOTIFICATION OF NON-CONFORMANCE WAS PROVIDED TO 3DMAX PERSONNEL FOCUSING ON CLEANLINESS AND PRODUCT VISUAL INSPECTION ACCEPTANCE CRITERIA. THE WARNING SECTION OF IFU STATES "THE MESH IS SUPPLIED STERILE. INSPECT THE PACKAGING TO BE SURE IT IS INTACT AND UNDAMAGED PRIOR TO USE." UPDATED FIELDS: B4, G3, G6, H2, H3, H6, H10. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    AS REPORTED, DURING ROUTINE INSPECTION AFTER RECEIVING THE GOODS, THE DISTRIBUTOR DISCOVERED UNKNOWN BLUE FILAMENTOUS SUBSTANCES INSIDE THE TRANSPARENT INNER PACKAGING OF THE PATCH. THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS PROPERLY SEALED BEFORE OPENING.

    Description of Event or Problem · 0

    AS REPORTED, DURING ROUTINE INSPECTION AFTER RECEIVING THE GOODS, THE DISTRIBUTOR DISCOVERED UNKNOWN BLUE FILAMENTOUS SUBSTANCES INSIDE THE TRANSPARENT INNER PACKAGING OF THE PATCH. THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS PROPERLY SEALED BEFORE OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165187 3DMAX LIGHT SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUJZ0941 00801741031038

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other