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 RE9CIC-W-MP manufactured by Gn Hearing A/s.
[189006402]
Allergic reaction occasionally happens, especially to sensitive people. No adverse trend seen. Investigation closed without any further action except trending. Additional to s/n (b)(4) - right. Additional to mfg date 11/09/2019 - right.
Patient Sequence No: 1, Text Type: N, H10
[189006423]
Possible allergic reaction. Patient developed a skin irritation/itching in outer ear canal from her ite (in the ear) cics (completely in canal) but there were not openings (cuts or blisters) in the skin. She reported to an urgent care for medication. Medication was prescribed at urgent care, type of medication unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005650109-2020-00005 |
| MDR Report Key | 9597525 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-11-25 |
| Date Mfgr Received | 2019-12-17 |
| Device Manufacturer Date | 2019-11-09 |
| 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 | RE9CIC-W-MP |
| Operator | LAY USER/PATIENT |
| 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. Required No Informationntervention | 2020-01-16 |