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 2020-01-15 for RESOUND RE761-DRWC 20686202 manufactured by Gn Hearing A/s.
[175229566]
High sound in device potentially gave additional hearing loss of 10 db (measured). Patient also complaining about alleged tinnitus as a result of the event. Device has a built in protective system that limits output in order to avoid too high sounds (above 132 db). Investigation continues. Device returned and investigated and work according to specifications.
Patient Sequence No: 1, Text Type: N, H10
[175229567]
Patient was fitted with his first pair of hearing aids on monday (b)(6) 2019. On friday (b)(6) 2019 he was at home and received a phone call on his (b)(6). He picked up the call, then tapped "speaker phone" and lifted phone to his left hearing aid which he was wearing (patient has never attempted this situation in the past). Hcp indicates medium power receiver. Patient reports a painfully loud squeal in his left ear so he pulled the phone immediately away. Patient reports pain for a day, which has gone away, but now he also claim to have tinnitus, fullness, and decreased hearing on that side. Hcp tested the patient's hearing and his hearing has decreased by 10 db at 1. 5 and 2 khz after this event. The hcp said there is no physical damage apparent, no redness/swelling/physical injury noted to outer ear. Patient has not worn hearing aids since the incident, and hcp has recommended that he not wear the hearing aids until being seen by the hcp. The hcp is referring the patient to an ent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005650109-2020-00003 |
| MDR Report Key | 9592925 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2019-12-16 |
| Device Manufacturer Date | 2019-03-26 |
| Date Added to Maude | 2020-01-15 |
| 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 | 2020-01-15 |
| 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 | LATRUPBJERG 7 BALLERUP, 2750 DA 2750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2020-01-15 |