MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-25 for COMFORT ZONE NI manufactured by Comfort Zone.
[248391]
Rptr sent a flyer about an ear coning product and stated that the product was "dangerous & bogus. " the claims on the flyer make the product appear to be a medical device. Mfr unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003301 |
| MDR Report Key | 398217 |
| Date Received | 2002-04-25 |
| Date of Report | 2002-04-25 |
| Date Added to Maude | 2002-06-10 |
| 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 | 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 | COMFORT ZONE |
| Generic Name | EAR CONING |
| Product Code | JYH |
| Date Received | 2002-04-25 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | NOT APPLICABLE |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 387267 |
| Manufacturer | COMFORT ZONE |
| Manufacturer Address | PO BOX 6427 CHANDLER AZ 85246 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-04-25 |