MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-02-01 for RESOUND LT 962 19706802 manufactured by Gn Hearing A/s.
[134705745]
.
Patient Sequence No: 1, Text Type: N, H10
[134705746]
The patient had part of his ear removed (right ear) due to cancer. The patient is bearing both glasses and hearing aids. After the ear surgery, the patient wore his glasses and hearing aid as usual. The hearing aid laid over the wound side (the plastic covered wire to the loudspeaker) eventually caused the reopening of the wound causing him to have stitches to close the wound. After this intervention, the patients situation is unknown as we cannot reach him.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005650109-2018-00002 |
| MDR Report Key | 8295788 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-02-01 |
| Date of Report | 2019-11-09 |
| Date of Event | 2018-09-04 |
| Date Mfgr Received | 2018-10-10 |
| Device Manufacturer Date | 2016-11-12 |
| Date Added to Maude | 2019-02-01 |
| 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 P.O.BOX 130 |
| Manufacturer City | BALLERUP, DK-2750 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2750 |
| Manufacturer G1 | GN HEARING A/S |
| Manufacturer Street | LAUTRUPBJERG 7 P.O.BOX 130 |
| Manufacturer City | BALLERUP, DK-2750 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | DK-2750 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESOUND |
| Generic Name | LINX 3D |
| Product Code | ESD |
| Date Received | 2019-02-01 |
| Model Number | LT 962 |
| Catalog Number | 19706802 |
| Lot Number | 1726958641 |
| 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 P.O. BOX 130 BALLERUP, DK-2750 DA DK-2750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-01 |