MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-06 for MAJESTIC, DEFENDER 28080058 manufactured by Health Mor, Hmi.
[18613172]
We purchased a filter queen vacuum and three defender air filters for our home. We are a family of five with three children. My wife and i along with one of our children suffer from allergies. My wife and son take prescription allegra while i take otc meds to control. We felt the system would help with our indoor air quality but have noticed no difference. Equipment is registered as a class ii medical device with the fda. The vacuum is too bulky and heavy to use while the filters are large and noisy. Our children complained often about the noise. My wife has aggravated a shoulder muscle while using the vac and is now in physical therapy. The distributor claims that we suffer from buyer's remorse rather than accept that the equipment just isn't working as promised. It may work in other homes but not ours. Currently attempting to return to the company. Dates of use: 2008. Diagnosis or reason for use: hoping to reduce indoor allergens and improve air quality.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008902 |
| MDR Report Key | 1224183 |
| Date Received | 2008-11-06 |
| Date of Report | 2008-11-06 |
| Date of Event | 2008-10-01 |
| Date Added to Maude | 2008-11-17 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAJESTIC, DEFENDER |
| Generic Name | VACUUM CLEANER, AIR FILTER |
| Product Code | FRF |
| Date Received | 2008-11-06 |
| Model Number | 28080058 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1278925 |
| Manufacturer | HEALTH MOR, HMI |
| Manufacturer Address | STRONGSVILLE OH US |
| Brand Name | MAJESTIC, DEFENDER |
| Generic Name | VACUUM CLEANER, AIR FILTER |
| Product Code | FRF |
| Date Received | 2008-11-06 |
| Model Number | 0109906 |
| Operator | LAY USER/PATIENT |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 2 |
| Device Event Key | 1278926 |
| Manufacturer | HEALTH MOR, HMI |
| Manufacturer Address | STRONGVILLE OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-06 |