MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-24 for OTOVATION HEARING.COM NONE SHOWN, ONLY ON WEBPAGE manufactured by Ovation Hearing/ Westridge Marketing.
[109512236]
Product received from (b)(6) is listed at "fda registered" on their home page. The heading aids do not have labels on them as required (no manufacturer listed, no product name, no year of manufacture). The instruction books are incomplete. The products on their site are not shown on the medical device listing page. The company name is not listed either. Not by "(b)(6)" and not by "(b)(6)" which they claim is their corporation. They claim to be specification developer" but have no technical files, or ability to recall products and have no quality control procedures in place. How can this be an fda registered company.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077447 |
| MDR Report Key | 7544226 |
| Date Received | 2018-05-24 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-05-22 |
| Date Added to Maude | 2018-05-25 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OTOVATION HEARING.COM |
| Generic Name | HEARING AID, AIR CONDUCTION |
| Product Code | ESD |
| Date Received | 2018-05-24 |
| Model Number | NONE SHOWN, ONLY ON WEBPAGE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OVATION HEARING/ WESTRIDGE MARKETING |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-24 |