MAUDE Adverse Event Report: FLUOROSCOPY EXAM; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Fever (1858); Headache (1880); Pain (1994)

Event Date 12/20/2018

Event Type  Injury  

Event Description

Loss of use of arm for 24 hrs, fever, headache, pain, after having fluoroscopy exam done.

• Brand Name: FLUOROSCOPY EXAM
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• MDR Report Key: 8200078
• MDR Text Key: 131774710
• Report Number: MW5082646
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2018

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 83