FDA Adverse Event
Injury
Summary report: N
MRI TESLA 3
MDR report key: 13592247
·
Received February 23, 2022
Report
- Report Number
- MW5107673
- Event Type
- Injury
- Date Received
- February 23, 2022
- Date of Event
- October 11, 2021
- Report Date
- February 20, 2022
- Manufacturer
- UNK
- Product Code
- LNH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- Health Professional
- *
Narratives
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5107673 ON 03/31/2022; MFR UNKNOWN. PROCODE: LNH.
Description of Event or Problem · 0
MY (B)(6) SON RECEIVES MRIS EVERY 3 MONTHS FOR HIS BRAIN TUMOR. THIS WAS THE FIRST TIME HE WAS IN A TESLA 3. ALL OTHER TIMES HE WAS IN A 1.5 TESLA. NO CONTRAST WAS GIVEN. HE SUFFERED FROM STOMACH CRAMPS, LOSS OF APPETITE, PALE SKIN, SEVERE WEIGHT LOSS (WAS 1LB AWAY FROM BEING FAILURE TO THRIVE) PSYCHOTIC EPISODES, BONE AND NERVE PAIN, HOT AND FREEZING SENSATIONS, PEELING SKIN ON PALMS OF HANDS AND FEET AND HAIR LOSS. THESE SYMPTOMS LASTED AROUND 6-8 WEEKS ALTHOUGH HE IS STILL LOSING HAIR TO THIS DAY. I WANT TO SAY I DO NOT KNOW THE MANUFACTURER OF THE MRI BUT HIS TEST WAS DONE AT (B)(6) HOSPITAL IN (B)(6). FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1663460 | MRI TESLA 3 | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING | LNH | UNK | |||
| 1863102 | MRI TESLA 3 | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING | LNH | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Male | Other |