MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-09 for ASKU manufactured by Cochlear Bone Anchored Solutions Ab.
[182740880]
Additional information has been requested regarding the device details; however, have not been made available as of the date of this report. Should further information be provided, a supplementary report shall be submitted. This report is submitted on march 2, 2020.
Patient Sequence No: 1, Text Type: N, H10
[182740881]
Per the clinic, it was reported that the patient developed an infection at the implant site and was subsequently treated with antibiotics. The patient was seen for follow up and it was reported that skin overgrowth at the implant site had developed. Subsequently, the excess skin was cauterised and the patient was placed on oral antibiotics for a duration of one week. The patient continues to be clinically managed by their healthcare provider.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00783 |
| MDR Report Key | 9808797 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-03-09 |
| 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 |
| 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 | ASKU |
| Generic Name | COCHLEAR BAHA CONNECT SYSTEM |
| Product Code | LXB |
| Date Received | 2020-03-09 |
| Model Number | ASKU |
| Catalog Number | ASKU |
| 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 | 2020-03-09 |