MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-01 for BONEBRIDGE BCI601 BONE CONDUCTION IMPLANT manufactured by Med-el Elektromedizinische Geraete Gmbh.
[163224361]
The device has been explanted and should be returned to the manufacturer for evaluation. When available, a device failure analysis will be submitted as a follow up report.
Patient Sequence No: 1, Text Type: N, H10
[163224362]
On (b)(6) 2019 the user reported that he could not hear anything when using the audio processor (ap). No information was received from the hospital regarding this case until (b)(6) 2019 when the explant was delivered to (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710014-2019-00734 |
| MDR Report Key | 9138664 |
| Date Received | 2019-10-01 |
| Date of Report | 2019-10-01 |
| Date Mfgr Received | 2019-09-17 |
| Date Added to Maude | 2019-10-01 |
| 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 | LAURA SIMONOTTI |
| Manufacturer Street | FUERSTENWEG 77A |
| Manufacturer City | INNSBRUCK 6020 |
| Manufacturer Country | AU |
| Manufacturer Postal | 6020 |
| Manufacturer Phone | 57788 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BONEBRIDGE |
| Generic Name | BCI BONE CONDUCTION IMPLANT |
| Product Code | MPV |
| Date Received | 2019-10-01 |
| Model Number | BCI601 BONE CONDUCTION IMPLANT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH |
| Manufacturer Address | INNSBRUCK AU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-01 |