MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for BI300 IMPLANT 3MM 92128 manufactured by Cochlear Bone Anchored Solutions Ab.
[183356587]
This report is submitted on march 13, 2020.
Patient Sequence No: 1, Text Type: N, H10
[183356588]
Per the clinic, the patient experienced an infection (on an unknown date) at the abutment site whereby the abutment was removed. It is unknown what treatment was administered for the infection. The implant remains in-situ.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00699 |
| MDR Report Key | 9827708 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-18 |
| Report Date | 2020-03-13 |
| Date Reported to FDA | 2020-03-13 |
| Date Reported to Mfgr | 2020-02-18 |
| Date Added to Maude | 2020-03-12 |
| 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 |
| 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 | BI300 IMPLANT 3MM |
| Generic Name | COCHLEAR BAHA CONNECT SYSTEM |
| Product Code | LXB |
| Date Received | 2020-03-12 |
| Model Number | 92128 |
| Catalog Number | 92128 |
| 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 | 2020-03-12 |