BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMEND

    MDR report key: 7810305 · Received August 23, 2018

    Report

    Report Number
    2249852-2018-00007
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    May 30, 2018
    Report Date
    August 21, 2018
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    NPL
    UDI-DI
    00813954020471
    PMA / PMN Number
    K062846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING SEVERAL ATTEMPTS, COLLAGEN MATRIX, INC. WAS NOT ABLE TO OBTAIN PRODUCT LOT SPECIFIC IDENTIFIERS (I.E. LOT NUMBER, EXPIRATION DATE), THEREFORE, A FULL INVESTIGATION COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED DURING ROUTINE FOLLOW-UP VISIT, ONE WEEK AFTER THE INITIAL IMPLANTATION OF THE MEMBRANE, THE MEMBRANE WAS GONE. TYPICAL PRODUCT RESORPTION AS INDICATED IN THE INSTRUCTIONS FOR USE IS APPROXIMATELY 8 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652281 BIOMEND COLLAGEN DENTAL MEMBRANE NPL COLLAGEN MATRIX, INC. 0103Z 00813954020471

    Patients

    Seq Age Sex Outcome Treatment
    1 Other