MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-02-04 for FOOT CHOICE FOOT MASSAGER A2775 FTCHD manufactured by Yas Healthy Fitness Co. Ltd..
[1282636]
Md notified customer service via mail that she had burned her toes while using the foot choice foot massager. After a few weeks, her toes became infected and she had to have the tip of her 2nd toe amputated. Md said that she had very poor circulation and poor feeling in her feet. She stated that she used the heat function for entirely too long of a time frame and felt the burns were her fault. This happened in (b)(6) 2009. The unit was purchased in 2007 and she had used it frequently for almost 2 years. She continued to use the unit even after the incident without the heat feature because she loved the massage. The only reason that she contacted customer service is because her unit stopped working, so she returned it to see if it could be fixed as she would like to continue using it. She stated that her toes have healed and you can hardly barely tell anything happened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528424-2010-00001 |
| MDR Report Key | 1616644 |
| Report Source | 99 |
| Date Received | 2010-02-04 |
| Date of Report | 2010-02-03 |
| Date of Event | 2009-01-01 |
| Date Facility Aware | 2010-02-02 |
| Report Date | 2010-02-03 |
| Date Reported to FDA | 2010-02-03 |
| Date Added to Maude | 2010-10-15 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOOT CHOICE FOOT MASSAGER |
| Generic Name | FOOT CHOICE FOOT MASSAGER |
| Product Code | ISA |
| Date Received | 2010-02-04 |
| Model Number | A2775 |
| Catalog Number | FTCHD |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YAS HEALTHY FITNESS CO. LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-02-04 |