MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-20 for COCHLEAR? VISTAFIX? VXA300 ABUTMENT 7.5MM 92997 manufactured by Cochlear Bone Anchored Solutions Ab.
[62906368]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[62906369]
Per the clinic, the patient experienced skin overgrowth on the abutment. Subsequently, the patient underwent revision surgery under general anesthesia to excise the excess skin and for removal of the abutment on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2016-02515 |
| MDR Report Key | 6192193 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-20 |
| Date of Report | 2016-11-30 |
| Date of Event | 2016-11-28 |
| Date Mfgr Received | 2016-11-30 |
| Date Added to Maude | 2016-12-20 |
| 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 | MEDICAL ASSISTANT |
| 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 | MACQUARIE 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 | COCHLEAR? VISTAFIX? VXA300 ABUTMENT 7.5MM |
| Generic Name | COCHLEAR BAHA CONNECT SYSTEM |
| Product Code | FZE |
| Date Received | 2016-12-20 |
| Model Number | 92997 |
| Catalog Number | 92997 |
| Lot Number | 155998 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-12-20 |