MAUDE Adverse Event Report: CANDELA GENTLEMAX PRO; GMAX PRO

Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Supplemental mdr will be submitted upon completion of the device investigation.
Event or Problem Description
Clinic reported to technical support that a (b)(6) female patient with recent sun exposure experienced burns to lower left arm following a hair removal treatment with gentlemax pro laser system; system settings were reportedly set incorrectly by treatment therapist and the wrong wavelength was used during treatment.Red pigmented circles, blister, and burning sensation were reportedly present post-treatment.There was no device alarms reported.Patient was provided a tube of "burn aid," and was referred to a local burn unit, and admitted for care.It was not reported by the clinic what treatment the patient received at the burn unit.Upon follow-up with the clinic, it was reported that the patient experienced blisters, peeling, red-underlying skin; and hypopigmentation which has reportedly healed.
Additional Manufacturer Narrative
Clinic reported to technical support that a 27 year-old female patient, fitzpatrick skin type v, with recent sun exposure experienced burns to lower left arm following a hair removal treatment with gentlemax pro laser system; no test spot was done, system settings were reportedly set incorrectly by treatment therapist and the wrong wavelength was used during treatment; treating therapist thought was using the yag 1064nm wavelength (gmax) however the machine was actually set to the lase 755nm.Patient was treated on a 10/24mm 3ms lase zimmer 5.The gentlemax pro treatment guidelines states the following for skin types iv-vi and tanned skin: pre-treat with prescription strength hydroquinone for at least 2 weeks prior to treatment.Test small area and wait 1-2 weeks prior to treating entire area to evaluate tissue response.Dcd may need to be adjusted when altering fluence.Do not treat recently tanned skin.Allow tan to fade priorto treatment.Consider the 1064 nm for hair removal treatment on type v-vi skin type.Per the gentlemax pro treatment guidelines, untoward responses include: burning, blistering, scabbing, crusting, hyperpigmentation, hypopigmentation, purpura and/or herpes simplex activation, in rare cases, scarring may result.Treatment guidelines for the gentlemax pro were not followed.Therefore, the cause for this event can be traced to the user.The adverse event was caused partially or wholly by the user of the device.Follow up information provided on 02apr2019 states: the clinic had their machine serviced in the last 3 months and clinical training has been completed with attention focused on skin types and wavelength suitability.

• Brand Name: GENTLEMAX PRO
• Common Device Name: GMAX PRO
• Manufacturer (Section D): CANDELA; 530 boston post road; wayland MA 01778
• MDR Report Key: 8425257
• Report Number: 1218402-2019-00002
• Device Sequence Number: 347898
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 27 YR