MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-05 for WATER IONIZER UNK manufactured by Alp Chito.
[21384875]
Newspaper ad says product was fda approved. Customer checked with fda and all is false. Co is not even registered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035113 |
| MDR Report Key | 589071 |
| Date Received | 2005-04-05 |
| Date of Report | 2005-04-05 |
| Date Added to Maude | 2005-04-11 |
| 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 |
| 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 | WATER IONIZER |
| Generic Name | * |
| Product Code | JRS |
| Date Received | 2005-04-05 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 578919 |
| Manufacturer | ALP CHITO |
| Manufacturer Address | 10 BOND ST GREAT NECK NY 11021 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-04-05 |