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	12/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An alleged incident was reported by a dr (b)(6) on (b)(6) 2022 to ward photonics technical support in which a female patient claims she developed a "burn-like blister" after an a series of 4, eight-minute treatments.No doctor report was provided to the doctor nor the manufacturer (wp).According to doctor, client did not want to be contacted further.Note: patient continued to be treated, without-issue, for over a month after alleged incident (as of on (b)(6) 2023).According to doctor- the patient is unaware why there was a temporary-injury during a singular treatment-without reappearing before or since.Dr claims patient is continually happy with results seen.
Event or Problem Description
Patient claims to have received burn during lllt treatment using red led cold light.However, the doctor was not able to confirm that it was a burn, or that it occurred as a result of lllt treatment.

• Brand Name: ULTRASLIM DIGITAL
• Common Device Name: Fat reducing low level laser
• Manufacturer (Section D): WARD PHOTONICS; 1980 n atlantic ave.; ste 108; 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 ; 8003925950
• MDR Report Key: 16116993
• Report Number: 3010053203-2023-00001
• Device Sequence Number: 14869655
• Product Code: OLI
• UDI-Device Identifier: 00860925000338
• UDI-Public: 00860925000338
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 01/05/2023

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: 211112-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female