MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for BIA400 IMPLANT 4MM W ABUTMENT 10MM 93331 manufactured by Cochlear Bone Anchored Solutions Ab.
[182955403]
This report is submitted on 11 march 2020.
Patient Sequence No: 1, Text Type: N, H10
[182955404]
Per the clinic, the patient experienced infection at implant site, subsequently the device was explanted in (b)(6) 2019 (specific date not reported). Clinical management is ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00688 |
| MDR Report Key | 9814934 |
| Date Received | 2020-03-10 |
| Date of Report | 2020-02-14 |
| Date Facility Aware | 2020-02-14 |
| Report Date | 2020-03-11 |
| Date Reported to FDA | 2020-03-11 |
| Date Added to Maude | 2020-03-10 |
| 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 | BIA400 IMPLANT 4MM W ABUTMENT 10MM |
| Generic Name | COCHLEAR BAHA CONNECT SYSTEM |
| Product Code | MAH |
| Date Received | 2020-03-10 |
| Model Number | 93331 |
| Catalog Number | 93331 |
| Lot Number | COH1237892 |
| 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 | 2020-03-10 |