BEUDAMED
    FDA Adverse Event Summary report: N

    3M ESPE RETRACTION CAPSULE

    MDR report key: 3988104 · Received July 24, 2014

    Report

    Report Number
    9611385-2014-00007
    Date Received
    July 24, 2014
    Report Date
    June 17, 2014
    Manufacturer
    3M DEUTSCHLAND GMBH
    Product Code
    MVL
    PMA / PMN Number
    K093721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENTIRE BOX OF CAPSULES RETURNED TO 3M (B)(4) WERE FOUND TO BE REMOVED FROM THEIR PROTECTIVE FOIL WRAPPERS. THERE WERE TWO RETURNED THAT THE DOCTOR HAD ATTEMPTED TO USE, BUT THE TIP SEPARATED FROM THE CAPSULE BODY. THE REMOVAL FROM THE PROTECTIVE FOIL WRAPPERS IS A HANDLING ERROR, BECAUSE THE CAPSULES STORAGE IS DESCRIBED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    A DENTAL OFFICE RETURNED TWO CAPSULES OF 3M (B)(4) RETRACTION CAPSULE IN WHICH THE TIPS HAD BROKEN OFF DURING USE IN THE PATIENT'S MOUTH. NO ADVERSE HEALTH EFFECTS HAVE OCCURRED AS A RESULT OF THESE EVENTS AND THIS REPORT IS BEING MADE BECAUSE OF THE POTENTIAL FOR ASPIRATION OF THE SMALL PART. THE CAPSULES WERE STORED OUTSIDE OF THEIR PROTECTIVE PACKAGING, WHICH CONTRIBUTED TO THE NOTED BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435031 3M ESPE RETRACTION CAPSULE RETRACTION CAPSULE MVL 3M DEUTSCHLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1