MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH BREAST MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Component Missing (2306)

Patient Problems Bruise/Contusion (1754); Pain (1994)

Event Date 10/29/2018

Event Type  Injury  

Event Description

Reporter states that she went for an mri on (b)(6) 2018 for examination of her breasts.She laid down in the prone position but there was no padding, just a metal bar.She then noticed later that day that she had pain bruising along her sternum.The pain made it difficult to take deep breaths.She denies any other symptoms.

• Brand Name: BREAST MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH
• MDR Report Key: 8046016
• MDR Text Key: 126637786
• Report Number: MW5081107
• Device Sequence Number: 1
• Product Code: LNH
• 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: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 80