MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-16 for BONEBRIDGE BCI601 BONE CONDUCTION IMPLANT manufactured by Med-el Elektromedizinische Geraete Gmbh.
[168856932]
The device has not been explanted. If it should be explanted, it is to 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
[168856934]
An image was received which showed the bone conduction floating mass transducer (bc-fmt) extruding through the skin. There is no product deficiency alleged. Additional information has been requested from the field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710014-2019-00791 |
| MDR Report Key | 9195686 |
| Date Received | 2019-10-16 |
| Date of Report | 2019-10-16 |
| Date Mfgr Received | 2019-10-03 |
| Date Added to Maude | 2019-10-16 |
| 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 | 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 | 2019-10-16 |
| 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 | 2019-10-16 |