MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-22 for RESOUND LS961-DRW 20357810 manufactured by Gn Hearing A/s.
[100666474]
The end user has developed an ear infection shortly after purchasing new hearing aids. Potential sources of infections are if hands are not washed, if the hearing aids are not being proper cleaned and if there have been any scratches to the ear canal. The end user has seen a doctor and has had anti-biotic treatment. The end user is unsure how to clean the hearing aids properly. The left ear is very moist and produces a lot of wax. This makes a liveable environment to a fungus and it is recommended that the end user is routinely checked for earwax by a medical doctor. It has not been possible to obtain additional information about the case, as regarding handling of hearing aids outside the dispenser's office, exchange of domes/wax filters. We have no information regarding previous history of middle ear infection, cleaning process and hygiene and scratches in the ear canal, possibly causing the infection. The user has been fit bilaterally, but the infection only occurred in one ear, why it is unlikely that the type of material being used is the cause of the infection. The end user did not want to return the device as the fungus infection is believed not to root from the device itself, but is related to handling. Especially as the event occurred 2 month after start using the device. The user guide for ls961-drw (400344000 ug,rs linx2 and enya,rie,gb) do direct the end user to a hearing care professional: "consult a hearing care professional if you discover a foreign object in your ear canal, if you experience skin irritation, or if excessive ear wax accumulates with the use of the hearing instrument. ". In this case the end user correct contacted a hearing care professional according to instruction. Furthermore the user guide do instruct in how to clean the device. Since the end user has recovered. Further decisions: as the event resulted in an infection that required medical intervention it is reportable to authorities according to our procedures. The event must be reported to: (b)(6), fda as the model is sold in us. Notified body dqs.
Patient Sequence No: 1, Text Type: N, H10
[100666475]
Patient has developed an ear infection shortly after purchasing her new hearing aids.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005650109-2018-00001 |
| MDR Report Key | 7288549 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-22 |
| Date of Report | 2018-02-20 |
| Date of Event | 2017-07-28 |
| Date Mfgr Received | 2017-10-30 |
| Device Manufacturer Date | 2016-11-11 |
| Date Added to Maude | 2018-02-22 |
| 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 | AUDIOLOGIST |
| 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, 2750 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2750 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESOUND |
| Generic Name | LINX2 |
| Product Code | OSM |
| Date Received | 2018-02-22 |
| Model Number | LS961-DRW |
| Catalog Number | 20357810 |
| 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 2750 DA 2750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-22 |