MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-03 for BELTONE TST 963 19705405 manufactured by Gn Hearing A/s.
[140746191]
During the use of the hearing aid beltone tst963 -model, catalog no 19705405, the user experienced the following: ear started to itch, hurt and became inflamed within 24 hours of use. Symptoms was in ear canal. Since the hearing aid is equipped with a dome and the dome is placed into the ear canal, the issue relates to the dome and not to the hearing aid itself. Md prescribed ointment and antibiotic. Patient discontinued the use of the hearing aids for 7-10 days and reaction reoccurred when trying wearing them a second time. Allergic reaction is identified in the risk analysis and mitigated to an acceptable level though device design in compliance with standards for biological-compatability. Still allergic reactions can occur in rare cases. The clinical evaluation does evaluate allergic reactions and the user guide includes a safety notification instructing the hearing aid wearer to contact the hpc in case of skin irritation. Clinical conclusion on the case is that it cannot be excluded that the device (the dome) have been causing or contributing to the skin reaction and that the reaction required medical intervention (ointment and antibiotics). No lubricant was used during the fitting of the hearing aid and dome. The patient is currently not wearing any hearing aid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005650109-2019-00002 |
| MDR Report Key | 8477799 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-03 |
| Date of Report | 2019-04-03 |
| Date of Event | 2019-03-06 |
| Date Mfgr Received | 2019-03-06 |
| Device Manufacturer Date | 2018-09-18 |
| Date Added to Maude | 2019-04-03 |
| 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, DENMARK DK-2750 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2750 |
| Manufacturer G1 | GN HEARING A/S |
| Manufacturer Street | LAUTRUPBJERG 7, P.O.BOX 130 |
| Manufacturer City | BALLERUP, DENMARK DK-2750 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | DK-2750 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BELTONE |
| Generic Name | HEARING AID |
| Product Code | ESD |
| Date Received | 2019-04-03 |
| Returned To Mfg | 2019-03-06 |
| Model Number | TST 963 |
| Catalog Number | 19705405 |
| Lot Number | 866027352, 866027353 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GN HEARING A/S |
| Manufacturer Address | LAUTRUPBJERG 7 BALLERUP, DENMARK 2750 DA 2750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-03 |