MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-04-09 for UNKNOWN manufactured by Cochlear Bone Anchored Solutions Ab.
[72173690]
This report is submitted on april 10, 2017, by cochlear ltd. On behalf of cochlear americas. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[72173691]
Per the clinic, the patient experienced skin overgrowth at abutment site. Subsequently, the patient underwent revision surgery to remove the excess skin on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
[76989652]
Per the clinic, on (b)(6) 2017, the patient was placed under general anaesthesia in order to replace the abutment on the fixture. The implanted device remains insitu. This report is submitted june 7, 2017.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000034-2017-00606 |
| MDR Report Key | 6474692 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-09 |
| Date of Report | 2017-05-26 |
| Date of Event | 2017-03-13 |
| Date Mfgr Received | 2017-05-26 |
| Date Added to Maude | 2017-04-09 |
| 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 | MS. BIANCA HANLON |
| Manufacturer Street | 1 UNIVERSITY AVENUE |
| Manufacturer City | MACQAURIE UNIVERSITY, NSW 2109 |
| Manufacturer Country | AS |
| Manufacturer Postal | 2109 |
| Manufacturer Phone | 94286555 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | COCHLEAR BAHA VISTAFIX SYSTEM |
| Product Code | FZE |
| Date Received | 2017-04-09 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-04-09 |