MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-15 for THERASOLES NI manufactured by Therasoles.
[118206]
Rptr wishes to report an advertisement seen on television, in which medical claims are made regarding "therasole" shoe liners. Rptr states that the add showed a person with a "medical like appearance" in the commercial, who said that the shoe liners are made of firm materials and pieces of copper. These materials "work on pressure points on the feet to cure arthritis pain in feet, hips and knees. " rptr has reason to believe that the co is making unsubstantiated medical claims.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015223 |
| MDR Report Key | 201946 |
| Date Received | 1998-12-15 |
| Date of Report | 1998-12-15 |
| Date of Event | 1998-12-13 |
| Date Added to Maude | 1998-12-17 |
| 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 |
| 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 | THERASOLES |
| Generic Name | SHOE LINER |
| Product Code | KYS |
| Date Received | 1998-12-15 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 196153 |
| Manufacturer | THERASOLES |
| Manufacturer Address | * BRENTWOOD TN * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-12-15 |