MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMANS MRI ; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Burning Sensation (2146); Skin Inflammation (2443); Burn, Thermal (2530)

Event Date 11/05/2019

Event Type  Injury  

Event Description

Pt was receiving an mri of the lumbar spine and pelvis which took approx 1.5 hours to complete.Pt complained of feeling hot during procedure, and was informed this was normal.After the procedure, she described it as a burning pain on bilateral thighs during procedure.Upon assessment, the pt had redness and 2 blisters noted.Fda safety report id# (b)(4).

• Brand Name: SIEMANS MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.
• MDR Report Key: 9526060
• MDR Text Key: 173181643
• Report Number: MW5091918
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/23/2019

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR