MAUDE Adverse Event Report: Noras MRI products GmbH Breast BI 7 MR Coil Set 3T; MRI Coil

Model Number	Breast BI 7 MR Coil Set 3T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Type of Reportable Event	Serious Injury

• Brand Name: Breast BI 7 MR Coil Set 3T
• Common Device Name: MRI Coil
• Manufacturer (Section D): Noras MRI products GmbH; leibnizstrasse 4; hoechberg, bavaria 97204 ; GM 97204
• Manufacturer (Section G): Noras MRI products GmbH; leibnizstrasse 4; hoechberg, bavaria 97204 ; GM 97204
• Manufacturer Contact: manuel brueckner ; leibnizstrasse 4; hoechberg, bavaria 97204 ; GM 97204
• MDR Report Key: 50437730
• Report Number: 3004929307-2026-00004
• Device Sequence Number: 21229632
• Product Code: MOS
• UDI-Device Identifier: 04251269207389
• UDI-Public: 04251269207389
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K162651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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
• Operator of Device: Health Professional
• Device Model Number: Breast BI 7 MR Coil Set 3T
• Device Catalogue Number: 118890
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female