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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASA SRL M6 LASER THERAPY

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ASA SRL M6 LASER THERAPY Back to Search Results
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.
 
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Brand NameM6
Type of DeviceLASER 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 Key11461320
MDR Text Key239101842
Report Number3004724437-2021-00001
Device Sequence Number1
Product Code ILY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051922
Number of Events Reported1
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 Received03/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberF9000207
Device Catalogue NumberM6
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2019
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
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