MAUDE Adverse Event Report: CANON INC. XRAY CAMERA; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Device Problem Output Problem (3005)

Patient Problems Hair Loss (1877); Unspecified Eye / Vision Problem (4471); Unintended Radiation Exposure (4565)

Event Date 05/28/2022

Event Type  Injury  

Event Description

Hair loss and dental and eye; neighbors xray and thermal cameras.Unlicensed devices and coming from 2 directions.Causes severe eyes strain but radiation waves are visible.Area is not zoned for hospital activities and equipment is unlicensed.Housed in two adjacent homes.Fda safety report id # (b)(4).

• Brand Name: XRAY CAMERA
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): CANON INC.
• MDR Report Key: 14575727
• MDR Text Key: 293338157
• Report Number: MW5110044
• Device Sequence Number: 1
• Product Code: MQB
• 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
• Type of Report: Initial
• Report Date: 05/28/2022

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?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening; Disability; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Hispanic
• Patient Race: Asian, American Indian Or Alaskan Native