MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-02 for UNKNOWN manufactured by Cochlear Bone Anchored Solutions Ab.
[81663624]
Device details unavailable at the time of this report, this report is submitted on august 03, 2017, by cochlear ltd. On behalf of cochlear americas. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[81663625]
Per the clinic, the patient experienced skin overgrowth at abutment site. Subsequently the patient was placed under general anaesthesia on (b)(6) 2017 and underwent skin revision surgery to excise skin during an abutment change.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2017-01460 |
| MDR Report Key | 6762645 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-02 |
| Date of Report | 2017-07-24 |
| Date of Event | 2017-07-13 |
| Date Mfgr Received | 2017-07-24 |
| Date Added to Maude | 2017-08-02 |
| 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 | AUDIOLOGIST |
| 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 | UNKNOWN |
| Generic Name | COCHLEAR BAHA VISTAFIX SYSTEM |
| Product Code | FZE |
| Date Received | 2017-08-02 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | N/A |
| 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 | 2017-08-02 |