MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-11 for BIA400 IMPLANT 4MM W ABUTMENT 14MM 93338 manufactured by Cochlear Bone Anchored Solutions Ab.
[183087045]
This report is submitted on 12 march 2020.
Patient Sequence No: 1, Text Type: N, H10
[183087046]
Per the clinic, the patient experienced infection at abutment site and was treated with oral, topical and iv antibiotics, however the issue could not be resolved. Subsequently the patient was placed under general anaesthesia and underwent skin revision surgery and replaced abutment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2020-00650 |
| MDR Report Key | 9821607 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-11 |
| 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 | MS. KRISTEL KOHNE |
| 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 14MM |
| Generic Name | COCHLEAR BAHA CONNECT SYSTEM |
| Product Code | MAH |
| Date Received | 2020-03-11 |
| Model Number | 93338 |
| Catalog Number | 93338 |
| Lot Number | COH1129962 |
| 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 | 2020-03-11 |