MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-02-19 for RESOUND LT961 19706502 manufactured by Gn Hearing A/s.
[136473067]
Description: lt961 - ear infections. Patient was seen for hearing evaluation approximately 9 months ago at which time he had an external ear infection that subsequently resolved after ent treatment. Provider fit patient with lt961 and small open domes. Pt was fine for the first three months but saw provider with report of itching and swelling after that, in one ear. Pt was treated by ent but provider reports 5-6 infections, alternating between ears since then. During one episode (might have been the first one, provider is not able to tell accurately), swelling got bad enough that ent had to put a wick in ear to open up canal. Since then patient sees dr as soon as itching is experienced. Provider not sure if domes are causing it, but wanted to know if gn hearing had other domes we could give that might be "more hypoallergenic". Provider was told that these are the only domes we make. As an alternative the provider was by gn hearing suggested to fit the patient with acrylic molds with no color dyes on them and with short canal and large open vents. Provider wanted to stay with domes that are open for minimal contact and open fitting. As of today we have no more news about how the patient is doing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005650109-2019-00001 |
| MDR Report Key | 8349489 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-19 |
| Date of Event | 2019-01-21 |
| Date Mfgr Received | 2019-01-21 |
| Device Manufacturer Date | 2018-02-26 |
| Date Added to Maude | 2019-02-19 |
| 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, 2750 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2750 |
| Manufacturer G1 | GN HEARING A/S |
| Manufacturer Street | LAUTRUPBJERG 7 P.O. BOX |
| 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 | HEARING AID |
| Product Code | ESD |
| Date Received | 2019-02-19 |
| Model Number | LT961 |
| Catalog Number | 19706502 |
| Lot Number | 1826538631 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GN HEARING A/S |
| Manufacturer Address | LAUTRUPBJERG 7 P.O. BOX 130 BALLERUP, DENMARK DK-2750 DA DK-2750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-19 |