MAUDE Adverse Event Report: ASA SRL M6 LASER THERAPY

Model Number F9000207

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

The treatment was performed with the handpiece in contact with the skin without the interposition of creams or other means. The patient refused to be examined by the doctor for the evaluation of the incident and despite repeated requests, we are not able to have information on previous diseases of the patient and any medications taken, so it is not possible to make a clinical evaluation of the incident. The dhr check of the device and the history of its service interventions do not show any anomalies that could be related to anomalous laser emissions. The technical check carried out on march 02, 2021, confirms the regular functioning of the device, therefore a malfunction of the device itself is excluded. Despite repeated reminders of 24 feb, 4 march, and 5 march we have not received any further information for the evaluation of the patient's health status, so based on the analysis of the gathered data we believe that there are no further activities to be performed on the market. However, we will maintain a high level of market surveillance to monitor similar events. If the fda doesn't have any further notes regarding this case, we consider the case closed.

Event Description

The doctor reported that the patient claims a burn on her right knee and right hip. Three days after the treatment, the patient claimed a burn and said the laser caused the burn on her right knee, non-mention of the hip. The patient did state that saw teledoc and they gave her a cream for the said burn. The patient refuses to see the doctor to evaluate the claimed burn.

• Brand Name: M6
• Type of Device: LASER THERAPY
• Manufacturer (Section D): ASA SRL; via galileo galilei 23; arcugnano, 36057 ; IT 36057
• Manufacturer (Section G): ASA SRL; via galileo galilei 23; arcugnano, italy 36057 ; IT 36057
• Manufacturer Contact: lucio zaghetto ; via galileo galilei 23; arcugnano, italy 36057 ; IT 36057
• MDR Report Key: 11461320
• MDR Text Key: 239101842
• Report Number: 3004724437-2021-00001
• Device Sequence Number: 1
• Product Code: ILY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: F9000207
• Device Catalogue Number: M6
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 03/11/2021 Patient Sequence Number: 1