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

Model Number	60001
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	09/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Received a verbal report of a patient who had allegedly been burned during treatment the prior year.The healthcare provider mentioned the incident to an employee of manufacturer in context with another topic, and the incident was over one year old.No further information about whether the burn was ever confirmed by a health care professional or not.
Event or Problem Description
Received third person verbal report of a patient who allegedly was burned during treatment.

• Brand Name: ULTRASLIM
• Common Device Name: Fat reducing low level laser
• Manufacturer (Section D): WARD PHOTONICS; 1980 n atlanatic ave.; ste 1008; cocoa beach FL 32931
• Manufacturer Contact: daniel de pietro ; 1980 n atlantic ave.; ste. 1008; cocoa beach, FL 32931
• MDR Report Key: 15847882
• Report Number: 3010053203-2022-00001
• Device Sequence Number: 5027303
• Product Code: OLI
• UDI-Device Identifier: 00860925000307
• UDI-Public: 00860925000307
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160880
• 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): 11/15/2022

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: 60001
• Device Catalogue Number: 60001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2018
• 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