MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-12 for RESOUND LS961-DRW 19396902 manufactured by Gn Hearing A/s.
[141736908]
Manufacture date for: lot 1588127872: 10 oct 2015, lot 1587163304: 06 oct 2015.
Patient Sequence No: 1, Text Type: N, H10
[141736909]
Patient was first fit with hearing aids 3 years ago. Reaction of redness started 1 year ago, first at top of ear where receiver wire touches, progressing to skin on back of ear where the hearing aid case touches. Six months ago the oozing started at the redness areas. Initially the patient saw her primary care physician 1 year ago. The treatment at that time was rx cortisone ointment. Patient last saw the physician 6 months ago ((b)(6) 2018) the hcp tried a solution with moles skin between the hearing aid and the skin, this worked to stop the reaction, but was inconvenient. The reaction stopped and cleared up with stoppage of hearing aid use. No irritation associated with hi domes. Patient uses only a dry tissue to clean the hearing aids. As of 2019-03-18 no status report concerning the patients situation have been obtained (after 3 attempts to reach out to the patient). From the clinical evaluation: patient experiences contact allergy that started approximately one year ago. Patient has had the hearing aids for three years. Location is from the receiver wire at the top of the ear and the back of the ear where the hearing aid touches. Area is red and oozing and clears up when patient stops wearing the hearing aid. Patient cleans domes with dry tissue. Patient has seen primary care physician one year ago. Cortisone ointment was prescribed. Last doctor's visit was three months prior to filing complaint. Complaint was filed at (b)(6) 2018. Allergic reaction is identified in the risk analysis and mitigated to an acceptable level through device design by compliance with standards for biocompatibility. 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 hcp in case of skin irritation. Clinical conclusion on the case is that it cannot be excluded that the devices have been causing the reaction and that the reaction required medical intervention (cortisone ointment).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005650109-2019-00003 |
| MDR Report Key | 8508442 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date of Event | 2018-12-05 |
| Date Mfgr Received | 2018-12-05 |
| Device Manufacturer Date | 2015-10-10 |
| Date Added to Maude | 2019-04-12 |
| 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 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 | HEARING AID LINX2 |
| Product Code | ESD |
| Date Received | 2019-04-12 |
| Model Number | LS961-DRW |
| Catalog Number | 19396902 |
| Lot Number | 1587163304, 1588127872 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GN HEARING A/S |
| Manufacturer Address | LAUTRUPBJERG 7 P.O. BOX 130 BALLERUP, DENMARK DK2750 DA DK2750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-12 |