MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-10 for SOLUMBRA #1970 #4950 #2925 #3930 * manufactured by Wetmore Assoc, Inc..
[15610494]
Rptr had ordered some clothing (257. 75 worth). Rptr told them that they were very allergic to the sun and uv lights and that rptr has lupus. Rptr talked with a salesman on the phone, who said that the sage green color would work well for them. They did not work at all. Rptr had the worst lupus flare they have ever had after being exposed to the sun only 30 mins. 75% of rptr's back was covering in purple/black lesions. Rptr was very sick. This co claims their clothes provide protection from the sun and uv light. But rptr found they provide less protection than a regular long sleeve cotton shirt. Rptr wrote a letter to them and suggested they should not offer those clothes to people that are allergic to the sun or that have lupus. Rptr told them that the clothes did not work at all. They have not responded to rptr's letter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019111 |
| MDR Report Key | 281757 |
| Date Received | 2000-06-10 |
| Date of Report | 2000-06-10 |
| Date of Event | 2000-05-22 |
| Date Added to Maude | 2000-06-16 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLUMBRA |
| Generic Name | SUN PROTECTIVE CLOTHING |
| Product Code | MIW |
| Date Received | 2000-06-10 |
| Model Number | #1970 #4950 #2925 #3930 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 272656 |
| Manufacturer | WETMORE ASSOC, INC. |
| Manufacturer Address | 2815 WETMORE AVE. EVERETT WA 98201 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2000-06-10 |