MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-10 for OTOCLEAR 7280 * manufactured by Bionix Development Corp..
[5698393]
Patient reported to the organization the experience of feeling increased pressure during the irrigation procedure and then increased ear pain the morning. Review confirmed that the medical assistant utilized low pressure consistently and only adjusted the temperature during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4616565 |
| MDR Report Key | 4616565 |
| Date Received | 2015-03-10 |
| Date of Report | 2015-03-10 |
| Date of Event | 2014-09-22 |
| Report Date | 2015-03-10 |
| Date Reported to FDA | 2015-03-10 |
| Date Reported to Mfgr | 2015-03-19 |
| Date Added to Maude | 2015-03-19 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OTOCLEAR |
| Generic Name | EAR IRRIGATION SYSTEM |
| Product Code | KCP |
| Date Received | 2015-03-10 |
| Model Number | 7280 |
| Catalog Number | * |
| Lot Number | 120515GAJ |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIONIX DEVELOPMENT CORP. |
| Manufacturer Address | 5154 ENTERPRISE BLVD TOLEDO OH 43612 US 43612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-10 |