MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for BIA400 IMPLANT 4MM W ABUTMENT 8MM 93330 manufactured by Cochlear Bone Anchored Solutions Ab.
[186100428]
This report is submitted on march 24, 2020.
Patient Sequence No: 1, Text Type: N, H10
[186100429]
Per the clinic, the patient experienced recurrent inflammation and infections at the abutment site. The infection has been previously treated with antibiotics (type unknown). The abutment was removed and skin was excised on (b)(6) 2019. The device was explanted on (b)(6) 2020 under a general anaesthetic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00850 |
| MDR Report Key | 9870711 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-27 |
| Report Date | 2020-02-27 |
| Date Reported to Mfgr | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2016-04-28 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIA400 IMPLANT 4MM W ABUTMENT 8MM |
| Generic Name | COCHLEAR BAHA CONNECT SYSTEM |
| Product Code | MAH |
| Date Received | 2020-03-24 |
| Model Number | 93330 |
| Catalog Number | 93330 |
| Lot Number | COH857648 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2020-03-24 |