MAUDE Adverse Event Report: WARD PHOTONICS ULTRASLIM DIGITAL; Powered laser surgical instrument

Model Number	60008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blister (4537)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer received report of blisters on patient breast after use of device.According to the patient report, the blisters occured underneath clothing while undergoing skin exposure to red light on an adjacent area.Manufacturer first received notification of patient report from fda medwatch notification on march 24, 2023.Manufacturer has spoken to the healthcare proivder and learned that they had not seen the alleged blisters, and that the patient had continued treatments for a period of time after the alleged incident date.Manufacturer has unsuccessfully reached out to patient.Healthcare provider is in process of returning device for inspection by manufacturer, although the device continues operating normally according to the provider.
Event or Problem Description
Manufacturer received notification on 3/24/2023 of an event reported to fda by a patient.According to the medwatch notification, the patient aleges that two blisters formed on skin underneath her clothing following red light treatment.Patient narrative from the medwatch form (mw5115842): "on my 3rd visit for ultraslim red light therapy 2 blisters occurred on my left breast medial.The treatment was for my neck but the light was so positioned that it covered over my left breast which.I was wearing a two layer camisole and no additional covering was used.I told the owner about the blisters when she returned from being out of town.The next treatments were done using a mat that covered that area.Who knew this would become complicated.I didn't heal well as i've had many reconstructive surgeries on my chest as i am a breast cancer survivor.I have seen many doctors and i was told it would probably have to have a revision surgery on that breast.The owner (b)(6) was really sorry about it and wanted to talk to mr.(b)(6) the developer of the red light therapy.I just thought the fda should know about this hazard.".

• Brand Name: ULTRASLIM DIGITAL
• Common Device Name: Powered laser surgical instrument
• 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: 16643106
• Report Number: 3010053-2023-00003
• Device Sequence Number: 5367709
• Product Code: GEX
• UDI-Device Identifier: 00860925000338
• UDI-Public: 00860925000338
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Other
• 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: 220706-02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2022
• 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 Sex: Female