BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRU-PULSE

    MDR report key: 183417 · Received August 18, 1998

    Report

    Report Number
    1723352-1998-00001
    Event Type
    Injury
    Date Received
    August 18, 1998
    Manufacturer
    TISSUE MEDICAL LASERS, INC.
    Product Code
    GEX
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR CALLED TO SAY THAT HE IS BEING SUED FOR TREATMENT OF A PT IN 1996 WHO HAD "EXTENDED REDNESS AND SOME SCARRING" FROM 'SKIN RESURFACING'. THIS IS THE FIRST WORD CO (TMLI) HAD CONCERNING SUCH AN INJURY. DR STATED THAT HE DID NOT BELIEVE THE LASER WAS AT FAULT. FOR MORE INFO SEE ATTACHMENT: COMPLIANCE CLOSEOUT REPORT. THIS IS ALL OF THE DATA AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRU-PULSE PULSED CO2 LASER GEX TISSUE MEDICAL LASERS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *