MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-18 for FILTER QUEEN HEALTH-MOR * manufactured by Health-mor.
[19548028]
Pt purchased this product to help with their and spouse's allergies, it was fda approved to remove 99. 99 percent allergens as a medical device. Both br take allegra d presciption and this device has not shown to reduce anything. It is too noisey to operate in a room to sleep. Both have seen no proof it removes allergens as stated. The distributor says it works. Not in this house.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1027920 |
| MDR Report Key | 449217 |
| Date Received | 2003-03-18 |
| Date of Report | 2003-02-24 |
| Date of Event | 2001-10-12 |
| Date Added to Maude | 2003-03-24 |
| 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 | FILTER QUEEN HEALTH-MOR |
| Generic Name | DEFENDER AIR FILTRATION |
| Product Code | FRF |
| Date Received | 2003-03-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 438201 |
| Manufacturer | HEALTH-MOR |
| Manufacturer Address | 6000 LOMBARDO CTR SEVEN HILLS OH 44131 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-03-18 |