MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-10 for BIA400 IMPLANT 4MM W ABUTMENT 10MM 93331 manufactured by Cochlear Bone Anchored Solutions Ab.
[182701396]
This report is submitted on march 10, 2020.
Patient Sequence No: 1, Text Type: N, H10
[182701397]
Per the clinic, the patient experienced recurrent infections at the abutment site that were treated with antibiotics (oral and topical). The abutment was removed on (b)(6) 2020. The implant remains in-situ.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00691 |
| MDR Report Key | 9809347 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-10 |
| Date of Report | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-10 |
| 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 | MS. ROBERTA LOVEDAY |
| 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 | 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 |
| 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 | 2020-03-10 |