MAUDE Adverse Event Report: WARD PHOTONICS ULTRASLIM DIGITAL; Fat reducing low level laser

Model Number	60008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Alleged blisters / rash on patient skin following red light treatment.Patient claims to have been "burned." note that blisters were found under clothing, and not in areas of direct exposure to the light.
Additional Manufacturer Narrative
Patient claims to have been burned underneath her underwear by the light.She has since sought medical treatment for the alleged "burn." the results of the medical exam are not known to us.Note that the affected area was underneath clothing and not directly in the light.Also note that the apparent "blisters" appear to be more similar to some type of a skin infection.Device was inspected by manufacturer and all specifications are within requirements.

• Brand Name: ULTRASLIM DIGITAL
• Common Device Name: Fat reducing low level laser
• Manufacturer (Section D): WARD PHOTONICS; 1980 n atlantic ave.; suite 1008; cocoa beach FL 32931
• Manufacturer (Section G): WARD PHOTONICS; 1980 n atlantic ave.; suite 1008; cocoa beach FL 32931
• Manufacturer Contact: daniel depietro ; 1980 n atlantic ave.; suite 1008; cocoa beach, FL 32931 ; 3216264859
• MDR Report Key: 16643299
• Report Number: 3010053-2023-00004
• Device Sequence Number: 6061056
• Product Code: OLI
• UDI-Device Identifier: 00860925000338
• UDI-Public: 00860925000338
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K202361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 60008
• Device Catalogue Number: 60008
• Device Lot Number: 230109-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Sex: Female