MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-24 for BELTONE AMZ 9/63 20690905 manufactured by Gn Hearing A/s.
[146051417]
Medical device. S/n (as there are a pair of hearing aids): (b)(4). Device not available for investigation in ballerup.
Patient Sequence No: 1, Text Type: N, H10
[146051418]
The patient became hospitalized for neuritis (pain behind the right ear). He was treated by an md who is a neurologist. Medication was prescribed. Patient asked the md if the neuritis could be due to the new hearing aids (used since (b)(6) 2019), and the doctor said "maybe". It has not been able to obtain further information on the medical condition, except for the information that the neuritis only was related to behind the right ear. On the (b)(6) 2019 it was confirmed that the patient was doing fine and that he was using his old hearing aids again (true 62). During many years of sales in a lot of different markets (many million pcs of hearing aids) it has never been reported incidents of neuritis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005650109-2019-00004 |
| MDR Report Key | 8639651 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-24 |
| Date of Event | 2019-04-03 |
| Date Mfgr Received | 2019-04-04 |
| Date Added to Maude | 2019-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR LARS HAGANDER |
| Manufacturer Street | LAUTRUPBJERG 7 P.O. BOX 130 |
| Manufacturer City | BALLERUP, COPENHAGEN DK 2750 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK 2750 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BELTONE |
| Generic Name | HEARING AID AMAZE |
| Product Code | OSM |
| Date Received | 2019-05-24 |
| Model Number | AMZ 9/63 |
| Catalog Number | 20690905 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GN HEARING A/S |
| Manufacturer Address | LAUTRUPBJERG 7 BALLERUP, DK 2750 DA DK 2750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-05-24 |