MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-01-16 for RESOUND RE761-DRWC 20686202 manufactured by Gn Hearing A/s.
[175255333]
Patient probably sensitive and prone to receive ear infection when ear canal is partly occluded by e. G. Hearing aid. No increased trend seen. Investigation closed without any further action except trending. S/n (b)(4) - right. Mfg date 01/26/2019 - right.
Patient Sequence No: 1, Text Type: N, H10
[175255354]
Repeated ear infections that never occurred prior to hearing aids - ent keeps putting on cipro (anti-biotics). Has occurred 3-4 times in the last year - has pus in ear canal that antibiotic clears. Finding moisture inside of aid when checking for sns. Hcp recommends he change domes daily but does not want to open up power dome or use molds since domes easier to change. Patient not wearing hearing aids until infection clears since he wears w/o cleaning - he may be re-introducing the fungus on unclean domes/receivers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005650109-2020-00004 |
| MDR Report Key | 9597123 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date Mfgr Received | 2019-12-17 |
| Device Manufacturer Date | 2019-01-21 |
| Date Added to Maude | 2020-01-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARS HAGANDER |
| Manufacturer Street | LAUTRUPBJERG 7 |
| Manufacturer City | BALLERUP, COPENHAGEN 2750 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2750 |
| Manufacturer G1 | GN HEARING A/S |
| Manufacturer Street | LAUTRUPBJERG 7 |
| Manufacturer City | BALLERUP, 2750 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2750 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESOUND |
| Generic Name | LINX QUATTRO |
| Product Code | OSM |
| Date Received | 2020-01-16 |
| Model Number | RE761-DRWC |
| Catalog Number | 20686202 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GN HEARING A/S |
| Manufacturer Address | LAUTRUPBJERG 7 BALLERUP, 2750 DA 2750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-16 |