BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRAMID BLACK 3/0 (2) 45CM HS15

    MDR report key: 3810532 · Received April 16, 2014

    Report

    Report Number
    2916714-2014-00250
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    B.BRAUN SURGICAL S.A.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE US, HOWEVER; PROCESSES ARE SHARED WITH PRODUCTS REGISTERED IN US. US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFG SITE EVAL: SAMPLES RECEIVED: 1 BOX WITH 12 UNITS. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. PRE-PRINTED BOX OF THE SAMPLE IS FOR DAFILON, BUT FRONTAL AND ADD'L BOX LABELS ARE FROM SUPRAMID. PRODUCT INSIDE IS ALSO SUPRAMID AND ACCORDING TO THE BOX LABEL. THIS MISTAKE TOOK PLACE AT THE MOMENT OF SELECTION OF PRE-PRINTED BOX OF THE PRODUCT IN THE WAREHOUSE. THE PERSON WHO WAS RE-CONDITIONING THE PRODUCT MANUALLY, SELECTED A WRONG PRE-PRINTED BOX. FINAL CONCLUSION: THE COMPLAINT IS CORRESPONDING (JUSTIFIED). CORRECTIVE/PREVENTIVE ACTIONS: OEM HAS OPENED A CORRECTIVE ACTION IN ORDER TO AVOID THIS KIND OF INCIDENTS IN THE FUTURE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE TEXT ON THE PRODUCT IS INACCURATE. IT IS A SUPRAMID THREAD, THE LABEL ON THE PACKAGE INDICATES DAFILON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233574 SUPRAMID BLACK 3/0 (2) 45CM HS15 MESH PRODUCTS FOR INCONTINENCE FTL B.BRAUN SURGICAL S.A. G0712051 613453V003

    Patients

    Seq Age Sex Outcome Treatment
    1