MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-20 for MAGNETOM AERA 10432914 manufactured by Siemens Healthcare Gmbh- Mr.
[177345405]
Additionally, the patient stated: "i do not believe the mri was the root cause of my severe pain and broken tooth. The condition in my knee pre-existed and was aggravated by the mri. In my case, there was no reason to believe i would encounter this pain during the mri procedure (e. G. No metal in the knee etc. } and the mri created a condition for negative or adverse consequences. " siemens is conducting a thorough investigation of the reported events. As this event is under investigation, a root cause has not yet been determined. A supplement report will be filed upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[177345406]
It was reported to siemens that an adverse event occurred while operating the magnetom aera system. A patient reported directly to the health canada authority that during an mri examination of his knee he felt severe and unexpected pain in his knee. The patient clenched his teeth to tolerate the pain and while doing so he broke a tooth. The broken tooth required dental surgery. The customer was unaware of any issue at the time of the event. Siemens has requested additional information in order to conduct an investigation of the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808157-2020-15561 |
| MDR Report Key | 9606942 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-08 |
| Date of Event | 2018-11-20 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-01-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MEREDITH ADAMS |
| Manufacturer Street | 40 LIBERTY BLVD. 65-1A |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104486461 |
| Manufacturer G1 | SIEMENS HEALTHCARE GMBH- MR |
| Manufacturer Street | HENKESTRASSE 127 |
| Manufacturer City | ERLANGEN, GERMANY 91052 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91052 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGNETOM AERA |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2020-01-20 |
| Model Number | 10432914 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH- MR |
| Manufacturer Address | HENKESTRASSE 127 ERLANGEN, GERMANY 91052 GM 91052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-20 |