MAUDE Adverse Event Report: ILLUMINOSS MEDICAL, INC. ILLUMINOSS; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES, IN-VIVO CURED, LIGHT-ACTIVATED

Device Problem Burst Container or Vessel (1074)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907)

Event Date 09/21/2023

Event Type  Death  

Event Description

My husband had a fractured humerus and a rod was recommended.On the morning of the surgery, the surgeon told us he would be using some kind of liquid product which hardens.I later found out it was a product called illuminoss.During insertion of the first balloon, it burst and my husband immediately began having issues with breathing.It was believed the liquid got into his bloodstream and he had an adverse response.They stabilized him and inserted another balloon, which also burst.They continued with a third.When they were done, my husband had complications due to the fluid from the product making its way to his lungs and ultimately killing him within six hours.This is a deadly product and the public needs to be made aware of the serious adverse side effects.I was told it was illuminoss.

Event Description

Additional information received for report mw5154024 on 2/23/2024 to add and additional device.Refrence report: mw5154150.

• Brand Name: ILLUMINOSS
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES, IN-VIVO CURED, LIGHT-ACTIVATED
• Manufacturer (Section D): ILLUMINOSS MEDICAL, INC.
• MDR Report Key: 19151775
• MDR Text Key: 340859430
• Report Number: MW5154024
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2024
• Patient Sequence Number: 1
• Treatment: VITAMINS
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic
• Patient Race: White