MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-22 for BREATHTEK SOLUTION manufactured by Otsuka America.
[5752279]
I recently learned that you (fda) have approved the breathtek solution for use in children. This product should have been removed from the market entirely. No child or adult should experience the pain i suffer from after consuming this solution. I notified the co and registered a complaint to the fda in 2011. I suffer from burning hand and feet syndrome after consuming this product. I still suffer today.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041665 |
| MDR Report Key | 4643317 |
| Date Received | 2015-03-22 |
| Date of Report | 2015-03-22 |
| Date of Event | 2015-01-01 |
| Date Added to Maude | 2015-04-01 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHTEK SOLUTION |
| Generic Name | BREATHTEK SOLUTION |
| Product Code | MSQ |
| Date Received | 2015-03-22 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTSUKA AMERICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-03-22 |