MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-20 for * 400105280200 manufactured by Siemens Medical Solutions Usa, Inc.
[3380177]
Burning sensation around neck occurred in mri. Since that time, when the patient's neck brace was taken off blisters had formed on both sides of neck where the patient felt the burning. The mri tech was interviewed. Prior to the mri, the patient did not complain of burning and all metal was removed during screening. Pt has skin hypersensitivity and may have had a reaction to the radiolucent sponges around mri coil. Radiologists reviewed images showing no artifact. Wound care is addressing the site. The patient openly admitted to having sensitive skin. The right side is worse than the left side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001504 |
| MDR Report Key | 3001504 |
| Date Received | 2013-02-20 |
| Date of Report | 2013-02-20 |
| Date of Event | 2013-01-16 |
| Report Date | 2013-02-20 |
| Date Reported to FDA | 2013-02-20 |
| Date Reported to Mfgr | 2013-03-13 |
| Date Added to Maude | 2013-03-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | COIL, MAGNETIC RESONANCE, SPECIALTY |
| Product Code | MOS |
| Date Received | 2013-02-20 |
| Model Number | * |
| Catalog Number | 400105280200 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC |
| Manufacturer Address | 51 VALLEY STREAM PARKWAY MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-20 |