FDA Adverse Event
Summary report: N
BOSTON SILVER TEE SHIRT
MDR report key: 1595383
·
Received January 8, 2010
Report
- Report Number
- 1595383
- Date Received
- January 8, 2010
- Date of Event
- January 6, 2010
- Report Date
- January 8, 2010
- Manufacturer
- COMFORT PRODUCTS, INC..
- Product Code
- IPT
- Report Source
- User Facility report
- Reporter Location
- RI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
(B) (6) WITH HX OF SCOLIOSIS HAD MRI OF SPINE AND BRAIN. SHE WAS ALLOWED TO WEAR A WHITE TEE SHIRT WHICH SHE WEARS UNDER HER CHEST BRACE. SHE WAS SEDATED DURING THE MRI. ONCE COMPLETED, PT HAD FIRST AND SECOND DEGREE BURNS ON HER CHEST. RADIOLOGIST CONTACTED MANUFACTURER AND FOUND THAT THERE ARE SILVER THREADS IN THE SHIRT NOT VISIBLE TO THE EYE. LABEL DOES NOT STATE ANYTHING ABOUT SILVER THREAD. MANUFACTURER RESPONSE (AS PER REPORTER) FOR COTTON TEE WORN UNDER CHEST BRACE, BOSTON SILVER TEE SHIRT;THEY HAVE BEEN SELLING THE TEE SHIRT FOR 7 YRS WITH NO INCIDENT. THEY WILL CONSIDER PUTTING A LABEL IN THE SHIRT WITH APPROPRIATE INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BOSTON SILVER TEE SHIRT | COTTON TEE WORN UNDER CHEST BRACE | IPT | COMFORT PRODUCTS, INC.. | NONE | NONE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR |