BEUDAMED
    FDA Adverse Event Other Summary report: N

    PEARL ER:YSGG LASER

    MDR report key: 2500889 · Received March 16, 2012

    Report

    Report Number
    2954354-2012-00009
    Event Type
    Other
    Date Received
    March 16, 2012
    Date of Event
    February 20, 2012
    Report Date
    March 16, 2012
    Manufacturer
    CUTERA
    Product Code
    GEX
    PMA / PMN Number
    K063867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED 3 MONTHS PRIOR TO THE REPORTED INCIDENT. NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION. THE DEVICE DID NOT MALFUNCTION. DEVICE OPERATOR MANUAL AND GUIDELINES STATE THE FOLLOWING: PATIENTS ARE MORE SUSCEPTIBLE TO IRRITATION OR INFECTION FOLLOWING PROCEDURES THAT DISRUPT THE SURFACE OF THE SKIN. IF THIS OCCURS, IT IS IMPORTANT TO PROPERLY DIAGNOSE AND TREAT THESE CONDITIONS IN ORDER TO AVOID DELAYED WOUND HEALING, SCARRING, OR SPREAD OF AN INFECTION. TREATMENT FOR THESE CONDITIONS OFTEN REQUIRES PRESCRIPTIVE MEDICATIONS.

    Description of Event or Problem · 1

    TREATMENT DAY: LASER ABLATIVE PROCEDURE TO FACE, NECK, CHEST. POST-OP DAY # 1: USER FACILITY REPORTED: PATIENT USED POST TREATMENT RECOVERY KIT PROVIDED BY USER FACILITY FOR POST-OPERATIVE SKIN CARE TO FACE, NECK AND CHEST. POST-OP DAY # 2: PATIENT DID NOT USE RECOVERY KIT FOR SKIN CARE. PER USER FACILITY REPORT: PATIENT DID NOT PERFORM POST OPERATIVE SKIN CARE TO THE OPERATIVE AREA ON POST-OPERATIVE DAY # 2. POST-OP DAY # 3: PRESENTED TO USER FACILITY FOR POST OPERATIVE FOLLOW UP APPOINTMENT. USER FACILITY REPORTED PATIENT PRESENTED WITH "100.5 F AXILLARY FEVER" AND "GREEN DRAINAGE" IN OPERATIVE AREA. PATIENT SENT TO E.R. BY USER FACILITY. PATIENT DIAGNOSED WITH "INFECTION, AND GIVEN ANTIBIOTICS." OPERATIVE AREA DEBRIDED BY E.R. DOCTOR." PATIENT PRESCRIBED ANTIBIOTICS AND PAIN MEDICATION. DISCHARGED FROM E.R.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEARL ER:YSGG LASER POWERED LASER SURGICAL INSTRUMENT (GEX) GEX CUTERA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention WOUND CARE. (DATE OF TX: (B)(6) 2012)| PEARL FRACTIONAL ER:YSGG LASER| MEDROL DOSE PACK| REST & RECOVER KIT BY BIOPELLE FOR POST-OPERATIVE