BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIMATIC

    MDR report key: 7725524 · Received July 27, 2018

    Report

    Report Number
    2411797-2018-00001
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    March 17, 2014
    Report Date
    July 24, 2018
    Manufacturer
    PARKELL, INC.
    Product Code
    EKZ
    PMA / PMN Number
    K950239
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PARKELL RECEIVED A SUBPOENA FROM THE STATE OF (B)(6) TO APPEAR FOR DEPOSITION ON JULY 6, 2018 FOR AN INCIDENT THAT OCCURRED ON (B)(6) 2014 WITH A PARKELL 500SE. PARKELL HAD NOT BEEN CONTACTED BY THE PATIENT OR USER PRIOR TO THE SUBPOENA. AFTER APPEARING AT THE DEPOSITION, PARKELL DECIDED TO FILE THIS MDR. PER THE SUBPOENA: "THE MANNER IN WHICH DEFENDANT, (B)(6), D.D.S., USED THE ELECTROSURGE, WHICH RESULTED IN HIGH HEAT PRODUCTION, CAUSING DAMAGE TO THE SURROUNDING SOFT TISSUE, BONE, AND LOSS OF THE DENTAL IMPLANT. THE RESULTING INJURY REQUIRES EXTENSIVE SURGICAL RECONSTRUCTION." THERE HAVE BEEN NO OTHER SIMILAR EVENTS OR MDR REPORTABLE EVENTS RELATED TO THE PARKELL SENSIMATIC 500SE. THE PARKELL SENSIMATIC 500SE WAS MANUFACTURED FROM 1995-1999.

    Description of Event or Problem · 1

    (B)(6), D.D.S. USED THE ELECTROSURGE, WHICH RESULTED IN HIGH HEAT PRODUCTION, CAUSING DAMAGE TO THE SURROUNDING SOFT TISSUE, BONE, AND LOSS OF THE DENTAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569928 SENSIMATIC ELECTROSURGICAL DEVICES EKZ PARKELL, INC. 500SE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention