MAUDE Adverse Event Report: LIGHT THERAPY; LAMP, INFRARED, THERAPEUTIC HEATING

Patient Problems Dyspnea (1816); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

Pt reports over the past month, having had any new red patches or an increase in skin itching or burning that is related to their skin condition.Pt reports they were having a flare up of psoriasis in their legs and was doing light therapy to help, but it seemed to worsen.Pt reports they were having burning from the light therapy.Pt washed their legs and the dead skin came off; it has been cleaned by caretaker and fluids removed.Pt reports their otezla md is aware and prescribed them zoryve.Author advised pt to speak to their md about psoriasis therapy since they feel like otezla isn't helping.Pt has an appointment with their otezla prescriber today (b)(6) 2023 to discuss.Pt also reports they have had changes in breathing: shortness of breath.No changes in pah symptoms reported.Pt's tyvaso goal is to get off of oxygen; has not met goal.Pt reports their pah md is aware.No further info, details or dates available.Reported to (b)(6) by pt/caregiver.

• Brand Name: LIGHT THERAPY
• Type of Device: LAMP, INFRARED, THERAPEUTIC HEATING
• MDR Report Key: 18065124
• MDR Text Key: 327526873
• Report Number: MW5147710
• Device Sequence Number: 1
• Product Code: ILY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: OTEZLA 30 MG, MFR: AMGEN; TYVASO NEBULIZER ; TYVASO REFILL KIT
• Patient Sex: Female