MAUDE Adverse Event Report: PET/CT SCAN; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Gastrointestinal Problem (4491)

Event Date 11/08/2021

Event Type  Injury  

Event Description

After scanning by 64 cu dotatate pet/ct i started having noise and growling stomach, no pain.I still have it after 2 months.Not listed in side effects of the scan.This is about side effect of injection.Radiomdx.Fda safety report id# (b)(4).

• Brand Name: PET/CT SCAN
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• MDR Report Key: 13178788
• MDR Text Key: 283498845
• Report Number: MW5106512
• Device Sequence Number: 1
• Product Code: KPS
• 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: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: CALCIUM; CRESTOR 5MG; MAGNISUM; PANTAPROZOLE 40MG ; VITAMIN A; VITAMIN D
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White