MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-29 for BIONIX OTOCLEAR EAR IRRIGATION SYSTEM #7280 manufactured by Bionix Development Corp..
[44473152]
Bionix otoclear ear irrigation system, product #7280, includes a waterpik water flosser, model wp-440, that contains a package insert with two warnings on page 3 to not use in ears. The warnings read, "do not direct water under the tongue, into the ear, nose, or other delicate areas. This product is capable of producting pressures that may cause serious damage in these areas", and "do not direct water into the nose or ear. The potentially deadly amoeba, naegleria fowleri, may be present in some tap water or unchlorinated well water and may be fatal if directed into these areas". This product is not compounded or an over-the counter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062068 |
| MDR Report Key | 5630042 |
| Date Received | 2016-04-29 |
| Date of Report | 2016-04-29 |
| Date Added to Maude | 2016-05-04 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | BIONIX OTOCLEAR EAR IRRIGATION SYSTEM |
| Generic Name | BIONIX OTOCLEAR EAR IRRIGATION SYSTEM |
| Product Code | KCP |
| Date Received | 2016-04-29 |
| Model Number | #7280 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIONIX DEVELOPMENT CORP. |
| Manufacturer Address | TOLEDO OH 43612 US 43612 |
| Brand Name | WATERPIK WATER FLOSSER |
| Generic Name | WATERPIK WATER FLOSSER |
| Product Code | EFS |
| Date Received | 2016-04-29 |
| Model Number | WP-440 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | WATERPIK INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-29 |