MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-04 for SENSEI BEHIND THE EAR manufactured by Oticon A/s.
[63812734]
Patient Sequence No: 1, Text Type: N, H10
[63812735]
The parent reported that the patient received a burn from the hearing aid while at home. The audiologist contacted the manufacturer for guidance on how to proceed. Manufacturer response for oticon sensei behind the ear, (brand not provided) (per site reporter): they "overnighted" a new device to the patient. They requested that the device in question be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6221073 |
| MDR Report Key | 6221073 |
| Date Received | 2017-01-04 |
| Date of Report | 2016-12-30 |
| Date of Event | 2016-11-28 |
| Report Date | 2016-12-08 |
| Date Reported to FDA | 2016-12-08 |
| Date Reported to Mfgr | 2016-12-08 |
| Date Added to Maude | 2017-01-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSEI BEHIND THE EAR |
| Generic Name | HEARING AIDE |
| Product Code | ESD |
| Date Received | 2017-01-04 |
| Returned To Mfg | 2016-12-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTICON A/S |
| Manufacturer Address | 29 SCHOOLHOUSE RD. SOMERSET NJ 08873 US 08873 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-04 |