MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-27 for RX 5000 HEARING AIDS RX5000 manufactured by Nano Advanced Hearing Technology.
[177022762]
I bought a pair of hearing aids from the company (b)(6) under a 60 day return policy. One of the hearing aids was defective and i called on (b)(6) 2019 to return the product. Just under the 60 day trial period. They refused to honor the return stated they changed their return policy to 45 days. I have an email on my order and a (b)(6) post from (b)(6)stating the offer was on a 60 day trial period. The person i bought this for is an (b)(6) lady who was and still is disappointed about this. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092538 |
| MDR Report Key | 9636564 |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-23 |
| Date of Event | 2019-12-25 |
| Date Added to Maude | 2020-01-28 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | 3 |
| Brand Name | RX 5000 HEARING AIDS |
| Generic Name | HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY |
| Product Code | OSM |
| Date Received | 2020-01-27 |
| Model Number | RX5000 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NANO ADVANCED HEARING TECHNOLOGY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-27 |