MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-25 for BIA300 IMPLANT 4MM W ABUTMENT 9MM 92346 manufactured by Cochlear Bone Anchored Solutions Ab.
[185970337]
This report is submitted on march 26, 2020.
Patient Sequence No: 1, Text Type: N, H10
[185970338]
Per the clinic, per the clinic, it was reported that the patient underwent revision surgery on (b)(6) 2020, in order to excise excess skin at the implant site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00821 |
| MDR Report Key | 9881657 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BIA300 IMPLANT 4MM W ABUTMENT 9MM |
| Generic Name | COCHLEAR BAHA CONNECT SYSTEM |
| Product Code | LXB |
| Date Received | 2020-03-25 |
| Model Number | 92346 |
| Catalog Number | 92346 |
| Lot Number | ASKU |
| 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 | 2020-03-25 |