MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for HYPERBARIC CHAMBER manufactured by Unk.
[184639830]
I have witnessed multiple pts being treated with hyperbarics for cancer die. This is not a treatment for people with cancer. It actually feeds the cancer and makes it grow. (b)(6) wellness center in (b)(6) is treating multiple "off lab" non fda approved and selling it; 99% of the cancer pts treated there have died. Also, i have spent lots of money there with the false hope of a cure. The ceo will tell you it treats ingrown toenails to make a buck. She acts like she really cares but it's all about the money. Wish i had mine back. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093862 |
| MDR Report Key | 9865059 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-19 |
| Date Added to Maude | 2020-03-23 |
| 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 | 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 | HYPERBARIC CHAMBER |
| Generic Name | CHAMBER, HYPERBARIC |
| Product Code | CBF |
| Date Received | 2020-03-20 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-20 |