BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATRELLE TE SMOOTH 133S-MV-15-T

    MDR report key: 11446541 · Received March 9, 2021

    Report

    Report Number
    9617229-2021-02673
    Event Type
    Malfunction
    Date Received
    March 9, 2021
    Report Date
    August 5, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LCJ
    UDI-DI
    10888628043893
    PMA / PMN Number
    K182054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FI RESULTS: SAMPLING TEST INSPECTION (315 EA) WAS PERFORMED. AS PER THE CORRESPONDING PROCEDURE, VISUAL AND PHYSICAL INSPECTION WERE PERFORMED, AND ALL COMPONENTS WERE NOTED CONFORMANT DURING THE TESTING. 4078 EA WERE RELEASED ON DECEMBER 17, 2019. IN ADDITION, THE PRIMARY PACKAGING EQUIPMENT LOG WAS VERIFIED AND ALL PARAMETERS (TEMPERATURE-TIME-PRESSURE) DURING THE PRIMARY PACKAGING PROCESS MET THE SPECIFICATIONS. SEE ¿020833 FORM¿ ATTACHED. REVIEW OF WORK ORDER 3413995 AND THE EVENT "FOREIGN MATERIAL ON IMPLANT (PARTICLE INSIDE PACKAGE)" DID NOT IDENTIFY ANY NCS OR CAPA ASSOCIATED WITH THIS INFORMATION.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: WHITE PARTICLES OUTER DEVICE AND DEVICE APPEARANCE(A BROWN PARTICLE IS OBSERVED ON THE SHELL WITH A ROUGH ASPECT AND WITH A MEASUREMENT OF 6.0MM, IT WILL BE SENT TO ANALYZE) LEAK TEST ANALYSIS WAS PERFORMED WHICH IDENTIFIED: DEVICE NO LEAK. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: FOREIGN MATERIAL WAS OBSERVED ON THE SURFACE OF THE SHELL, HOWEVER EXTERNAL LABORATORY ANALYZES CONCLUDED THAT IT IS NOT POSSIBLE TO IDENTIFY THE OBSERVED PARTICLE. ADDITIONALLY, THE EXTERNAL LABORATORY ANALYSIS IS ATTACHED. BASED ON THE ANALYSIS, WORKMANSHIP IS NOT CONSIDERED, DUE TO THE FACT THAT THE DEVICE IS NOT RECEIVED IN ITS ORIGINAL SEALED PACKAGING. THE EXTERNAL LABORATORY RESULTS WERE INCONCLUSIVE DUE TO THE SIZE OF THE PARTICLE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED AN IMPLANT WITH "RANDOM MATERIAL STUCK ON IT." DEVICE WAS NOT IMPLANTED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED AN IMPLANT WITH "RANDOM MATERIAL STUCK ON IT." DEVICE WAS NOT IMPLANTED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED AN IMPLANT WITH "RANDOM MATERIAL STUCK ON IT." DEVICE WAS NOT IMPLANTED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AN IMPLANT WITH "RANDOM MATERIAL STUCK ON IT." DEVICE WAS NOT IMPLANTED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338794 NATRELLE TE SMOOTH 133S-MV-15-T EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) 133S-MV-15-T 3413995 10888628043893

    Patients

    Seq Age Sex Outcome Treatment
    1 Other