MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-19 for BIM400 IMPLANT MAGNET 93550 manufactured by Cochlear Bone Anchored Solutions Ab.
[184242492]
This report is submitted on march 20, 2020.
Patient Sequence No: 1, Text Type: N, H10
[184242493]
Per the clinic, the patient underwent revision surgery on (b)(6) 2020, in order to reposition the internal fixture due to the implant being too close to the pinna, causing the patient pain. The surgery was reported to be unsuccessful and subsequently, the internal magnet was explanted and a cover screw was placed. The patient will continue to be clinically managed by their healthcare provider for future reimplantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00757 |
| MDR Report Key | 9857730 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-19 |
| 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 | MRS BIANCA PRIES |
| 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 | 2020-03-19 |
| Model Number | 93550 |
| Catalog Number | 93550 |
| Lot Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-19 |