MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-09 for BIM400 IMPLANT MAGNET 93550 manufactured by Cochlear Bone Anchored Solutions Ab.
[182740987]
This report is submitted on 10 march 2020.
Patient Sequence No: 1, Text Type: N, H10
[182740988]
Per the clinic, it was reported that due to pain the internal magnet was removed on (b)(6) 2020 in order to convert the patient to a percutaneous baha implant system. An abutment was placed on the implant fixture, which remains insitu. No other event or complications which may have contributed to the decision to convert the patient were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00621 |
| MDR Report Key | 9809025 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-09 |
| 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 | MS. KRISTEL KOHNE |
| Manufacturer Street | 1 UNIVERSITY AVENUE |
| Manufacturer City | MACQUARIE UNIVERSITY, NSW 2109 |
| Manufacturer Country | AS |
| Manufacturer Postal | 2109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIM400 IMPLANT MAGNET |
| Generic Name | COCHLEAR BAHA ATTRACT SYSTEM |
| Product Code | LXB |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2020-02-12 |
| Model Number | 93550 |
| Catalog Number | 93550 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COCHLEAR BONE ANCHORED SOLUTIONS AB |
| Manufacturer Address | KONSTRUKTIONSV?GEN 14 PO BOX 82 M?LNLYCKE, 435 22 SW 435 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-09 |