MAUDE Adverse Event Report: Agfa N.V.

Device Problem Device Operational Issue (2914)

Patient Problem Radiation Exposure, Unintended (3164)

Event Type  Other  

• Manufacturer (Section G): Agfa N.V.; septestraat 27; mortsel B2640 ; BE B2640
• Manufacturer Contact: septestraat 27; mortsel B2640
• MDR Report Key: 8050966
• Report Number: COR18001718-000
• Device Sequence Number: 1
• Product Code: KPR
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No Information
• Patient Sequence Number: 1
• Patient Outcome(s): Other