BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNABLAST PASTE 0.5CC

    MDR report key: 3556936 · Received December 24, 2013

    Report

    Report Number
    3005990499-2013-00010
    Event Type
    Other
    Date Received
    December 24, 2013
    Date of Event
    September 1, 2013
    Report Date
    December 5, 2013
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NUN
    PMA / PMN Number
    K043573
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CONTRACT MANUFACTURED FOR KEYSTONE DENTAL BY (B)(4). KEYSTONE DENTAL HAS AN EXCLUSIVE LICENSE TO SELL THE DYNABLAST PRODUCT FOR DENTAL APPLICATIONS FROM (B)(4), THE DEVELOPER OF THE PRODUCT. NO ADD'L COMPLAINTS FROM THIS LOT WERE IDENTIFIED DURING A REVIEW OF KEYSTONE COMPLAINTS DATABASE. (B)(4) PERFORMED A DETAILED REVIEW OF THE MFG RECORDS WHICH INCLUDED (B)(6), DEMINERALIZE BATCH RECORD #12100114, AND VERIFIED THAT PRODUCT WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE PRODUCT SPECS. A REVIEW OF THE STERILIZATION CERTIFICATE OF PROCESSING VERIFIED THAT THE PRODUCT WAS STERILIZED ON (B)(4) 2013, IN LOAD 13D13 AND WAS STERILIZED FROM DOSE 28.2 KGY TO 30.8 KGY. THE PRODUCT WAS STERILIZED WITHIN SPECS OF MIN DOSE 25.0 KGY TO MAX DOSE 35.0 KGY. (B)(4) CERTIFIES THAT THE MATERIALS LISTED ABOVE (AS DESCRIBED BY ITS MFR) RECEIVED THE ABOVE DOSES WITHIN THE PRECISION AND ACCURACY OF THE DOSIMETRY SYSTEM EMPLOYED. THE PRODUCTS ARE TERMINALLY STERILIZED TO A STERILITY ASSURANCE LEVEL (SAL) OF 10-6. KEYSTONE DENTAL INVESTIGATION DID NOT REVEAL ANY MFG OR STERILIZATION ISSUES THAT MAY CONTRIBUTE TO THE REPORTED INCIDENT. THE PT HAS KNOWN SENSITIVITY TO MEDICAL TAPE. THE ROOT CAUSE OF THIS OCCURRENCE COULD NOT BE DETERMINED. KEYSTONE DENTAL REFERENCE: (B)(4).

    Description of Event or Problem · 1

    THE CLINICIAN CONTACTED KEYSTONE DENTAL ON (B)(6) 2013 AND REPORTED THAT A PT COMPLAINED OF ITCHINESS AND HIVES ALL OVER THE BODY SINCE THE DYNABLAST PROCEDURE ON (B)(6) 2013. THE PT HAS BEEN TAKING BENADRYL FOR THE SYMPTOMS SINCE (B)(6). ACCORDING TO THE INCIDENT NARRATIVE THE SITE WAS GRAFTED ON (B)(6) 2013, (B)(6) WAS NOT REPORTED. THE PT WAS PRESCRIBED AMOXICILLIN AFTER THE GRAFTING PROCEDURE. THE PT COMPLAINED OF HIVES AT THE ONE MONTH POST OP VISIT, THE PT WAS ADVISED TO STOP TAKING AMOXICILLIN. THE PT WAS SEEN IN EARLY (B)(6) AND NOTED THAT THE SYMPTOMS DID NOT SUBSIDE. THE PT DID NOT REPORT ANY ALLERGIES AT THE TIME OF SURGERY, BUT DID MENTION A KNOWN SENSITIVITY TO MEDICAL TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674540 DYNABLAST PASTE 0.5CC NUN KEYSTONE DENTAL NA 130638

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention COLLATAPE USED IN CONJUNCTION WITH DYNABLAST