BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASE

    MDR report key: 250651 · Received November 8, 1999

    Report

    Report Number
    2183911-1999-00001
    Event Type
    Other
    Date Received
    November 8, 1999
    Date of Event
    May 1, 1998
    Report Date
    November 8, 1999
    Manufacturer
    CLARUS MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON OCTOBER 27, 1999 THE DIRECTOR OF SALES AND MARKETING AT CLARUS MEDICAL RECEIVED A TELEPHONE CALL FROM PT. PT CLAIMED TO HAVE BEEN INJURED DURING A PERCUTANEOUS LUMBAR DISLECTOMY PROCEDURE IN WHICH THE SURGEON USED A CLARUS PRODUCT (LASE). CO'S RECORDS INDICATE A PRODUCT COMPLAINT WAS NOT MADE BY THE PHYSICIAN, INSTITUTION, SALESPERSON OR ANYONE ELSE CONCERNING THE USE OF THE PRODUCT. THE PRODUCT WAS NOT RETURNED. THE MODEL NUMBER, SERIAL NUMBER, LOT NUMBER AND DATE OF USE ARE ALL UNKNOWN. THE DIRECTOR OF SALES AT CO CONTACTED THE PHYSICIAN. SHORTLY AFTER RECEIVING THE TELEPHONE CALL, THE PHYSICIAN ACKNOWLEDGED KNOWING WHO PT WAS AND HE CLAIMS OF POSTOPERATIVE PAIN. THE PHYSICIAN MADE NO MENTION OF A DEFECTIVE CLARUS PRODUCT DURING THIS CALL. CLARUS IS FILING THIS REPORT BECAUSE OF THE PT CLAIMING INJURY CAUSED BY A CLARUS MEDICAL, INC PRODUCT. CLARUS MEDICAL DOES NOT HAVE ANY KNOWLEDGE OF A DEFECTIVE DEVICE FOR THIS EVENT. A TRANSCRIPT OF THE TELEPHONE CONVERSATION OF OCTOBER 27, 1999 WITH PT IS ATTACHED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASE PERCUTANEOUS LASER DISCECTOMY GEX CLARUS MEDICAL SYSTEMS, INC. 1100-(UNKNOWN) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other