MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-08 for BOSTON SILVER TEE SHIRT NONE manufactured by Comfort Products, Inc...
[1417331]
(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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1595383 |
| MDR Report Key | 1595383 |
| Date Received | 2010-01-08 |
| Date of Report | 2010-01-08 |
| Date of Event | 2010-01-06 |
| Report Date | 2010-01-08 |
| Date Reported to FDA | 2010-01-08 |
| Date Added to Maude | 2010-02-05 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | BOSTON SILVER TEE SHIRT |
| Generic Name | COTTON TEE WORN UNDER CHEST BRACE |
| Product Code | IPT |
| Date Received | 2010-01-08 |
| Model Number | NONE |
| Catalog Number | NONE |
| Lot Number | NONE |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMFORT PRODUCTS, INC.. |
| Manufacturer Address | 705 LINTON AVE. CROYDON PA 19021 US 19021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-08 |