BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIST

    MDR report key: 5675260 · Received May 24, 2016

    Report

    Report Number
    3003898228-2016-00005
    Event Type
    Malfunction
    Date Received
    May 24, 2016
    Date of Event
    April 7, 2016
    Report Date
    October 17, 2016
    Manufacturer
    FH INDUSTRIE
    Product Code
    MOO
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT RECALL // INCIDENT REPORT (B)(4) : 21 IMPLANTS. QUANTITY:0000000242451 VIS SECABLE AUTOCOMPRESSIVE L26 F02301 1 (B)(6); 0000000231392 TETE INOX CONE 12-14 28CM (0) F02708 1 (B)(6); 0000000231392 TETE INOX CONE 12-14 28CM (0) F02708 1 (B)(6); 0000000231392 TETE INOX CONE 12-14 28CM (0) F02708 1 (B)(6); 0000000231392 TETE INOX CONE 12-14 28CM (0) F02708 1 (B)(6); 0000000257691 COMPOSANT FEM.PS A/C T.2 GHE FHK F03587 1 (B)(6); 0000000257691 COMPOSANT FEM.PS A/C T.2 GHE FHK F03587 1 (B)(6); 0000000257691 COMPOSANT FEM.PS A/C T.2 GHE FHK F03587 1 (B)(6); 0000000257691 COMPOSANT FEM.PS A/C T.2 GHE FHK F03587 1 (B)(6); 0000000257691 COMPOSANT FEM.PS A/C T.2 GHE FHK F03587 3 (B)(6);0000000257663 EMBASE TIBIALE PF A/C T.5 FHK F03661 1 (B)(6);0000000257663 EMBASE TIBIALE PF A/C T.5 FHK F03661 1 (B)(6); 0000000257663 EMBASE TIBIALE PF A/C T.5 FHK F03661 2 (B)(6); 0000000256693 CUPULE DOUBLE MOBILITE HNG T 56 RG01127 1 (B)(6); 0000000260132 *TETE INOX 12/14 ATHENA II 28 SS JUPE -4 RG01203 1 (B)(6); 0000000260133 *TETE INOX 12/14 ATHENA II 28 SS JUPE 0 RG01204 1 (B)(6); 0000000260134 *TETE INOX 12/14 ATHENA II 28 SS JUPE +4 RG01205 1 (B)(6);0000000254527 TETE ALUMINE 12/14 D.36 CL +3,5 RG01225 1 (B)(6).

    Description of Event or Problem · 1

    SEALING DEFECT IS DISCOVERED: THERE IS AN ERROR IN THE CALIBRATION PERFORMED BY EXTERNAL SERVICE COMPANY. THE BLISTER / SEALING FORMATTING HAS BEEN CARRIED OUT AT A VALUE LESS THAN THE MINIMUM TEMPERATURE VALIDATED.

    Description of Event or Problem · 1

    SEALING DEFECT IS DISCOVERED: THERE IS AN ERROR IN THE CALIBRATION PERFORMED BY EXTERNAL SERVICE COMPANY. THE BLISTER / SEALING FORMATTING HAS BEEN CARRIED OUT AT A VALUE LESS THAN THE MINIMUM TEMPERATURE VALIDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330939 LIST LIST MOO FH INDUSTRIE

    Patients

    Seq Age Sex Outcome Treatment
    1