FDA Adverse Event
Injury
Summary report: N
TOSHIBA MRI
MDR report key: 20452123
·
Received October 11, 2024
Report
- Report Number
- MW5161019
- Event Type
- Injury
- Date Received
- October 11, 2024
- Date of Event
- October 8, 2024
- Report Date
- October 8, 2024
- Manufacturer
- CANON MEDICAL INFORMATICS, INC.
- Product Code
- LLZ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
AFTER EXAM PATIENT COMPLAINED OF A BURNING SENSATION ON HIS RIGHT THUMB. UPON INSPECTION THERE IS A SMALL CIRCULAR BLISTER AND SURROUNDING REDNESS. PATIENT DID NOT DEEM TREATMENT WAS NEEDED NOR DESIRED. PATIENT RETURNED AN HOUR LATER STATING AND SHOWED THERE WAS AN AREA ON THE LATERAL SIDE OF THE RIGHT THIGH WITH SIMILAR APPEARANCE. PATIENT WAS APPROPRIATELY CLOTHED AND COVERED WITH DISPOSABLE SCRUB PANTS. NO METAL WAS PRESENT. AGAIN PATIENT DID NOT WISH TO SEEK TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1345360 | TOSHIBA MRI | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL | LLZ | CANON MEDICAL INFORMATICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Male | Other |