BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATRELLE TE SMOOTH 133S-MX-13-T, 500CC

    MDR report key: 17559566 · Received August 16, 2023

    Report

    Report Number
    9617229-2023-13564
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    July 27, 2023
    Report Date
    November 21, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LCJ
    UDI-DI
    04987836037256
    PMA / PMN Number
    K182054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: FOREIGN MATERIAL ON IMPLANT, THE DEVICE WAS NOT IMPLANTED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE IS RELATED TO THE REPORTED EVENT FOREIGN MATERIAL ON IMPLANT RECEIVED ON (B)(6) 2023, WITH LOT NUMBER 3635934. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: FOREIGN MATERIAL ON IMPLANT: OBSERVED AN ORANGE MATERIAL ON IMPLANT THAT WAS RECEIVED WITH AN OPENED INNER AND OUTER THERMOFORMS. THE ORANGE MATERIAL WAS SENT TO AN EXTERNAL LABORATORY TO COMPARE WITH TWO POTENTIAL SAMPLES FOUND IN THE MANUFACTURING PROCESS THROUGH SEM-EDX. SAMPLES CORRESPOND TO THERMAL RESISTANT TAPE (KAPTON) THAT ALSO HAVE AN ORANGE APPEARANCE. THE RESULTS SHOW THAT THE ORANGE MATERIAL HAD ADDITIONAL COMPONENTS DIFFERENT FROM THE SAMPLES TAKEN FROM THE MANUFACTURING PROCESS. THE CHEMICAL COMPOSITION OF THE ORANGE MATERIAL SHOWS A HIGH PERCENTAGE OF CHLORINE AND IODINE, WHICH ARE NOT USED IN THE MANUFACTURING PROCESS. ACCORDING TO THE COMPLAINT, THE COMPLAINANT SAYS THAT COULD BE ¿IODINE DRAPE¿, WHICH HAS SIMILAR COMPONENTS, SUCH AS IODINE, HOWEVER, IODINE DRAPE IS NOT USED IN THE MANUFACTURING PROCESS. ADDITIONALLY, DURING THE INSPECTION OF THE ORANGE MATERIAL IT SHOWS SOME ELASTICITY THAT IS NOT IN THE KAPTON TAPE USED IN THE MANUFACTURING PROCESS. DUE TO THE PREVIOUS POINTS, THE EVENT IS NOT CONSIDERED A WORKMANSHIP, HOWEVER, FURTHER INVESTIGATION 2813594 WAS OPENED TO ANALYZE THIS EVENT. ADDITIONAL OBSERVATIONS: THE DEVICE IS INTACT AND FUNCTIONAL. FURTHER INVESTIGATION 2813594 WAS OPEN TO ADDRESS THE EVENT OF FOREIGN MATERIAL ON IMPLANT.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "ORANGE TAPE" ON TISSUE EXPANDER. DEVICE WAS NEVER IMPLANTED. SURGERY WAS COMPLETED WITH A SUBSTITUTE DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "ORANGE TAPE" ON TISSUE EXPANDER. DEVICE WAS NEVER IMPLANTED. SURGERY WAS COMPLETED WITH A SUBSTITUTE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828837 NATRELLE TE SMOOTH 133S-MX-13-T, 500CC EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) 3635934 04987836037256

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention