MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for BIM400 IMPLANT MAGNET 93550 manufactured by Cochlear Bone Anchored Solutions Ab.
[185944797]
Per the clinic, it was reported that the patient experienced a wound dehiscence of the incision line subsequent to the formation of a fistula formation at the implant site. Subsequently, magnet removal surgery was scheduled for (b)(6) 2020. It is unknown whether the surgery has taken place, as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00855 |
| MDR Report Key | 9881531 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-02 |
| Date Facility Aware | 2020-03-02 |
| Report Date | 2020-03-26 |
| Date Reported to FDA | 2020-03-26 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIM400 IMPLANT MAGNET |
| Generic Name | COCHLEAR BAHA CONNECT SYSTEM |
| Product Code | LXB |
| Date Received | 2020-03-25 |
| Model Number | 93550 |
| Catalog Number | 93550 |
| Lot Number | ASKU |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-25 |