MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-05 for COCHLEAR? VISTAFIX? VXI300 IMPLANT 3MM 93100 manufactured by Cochlear Bone Anchored Solutions Ab.
[93772482]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[93772483]
Per the clinic, it was reported that the patient experienced an infection and skin over-growth at the implant site and was subsequently treated with an antibiotic ointment. The patient continues to be clinically managed by their healthcare provider. The implanted device remains insitu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2017-02208 |
| MDR Report Key | 7084499 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-05 |
| Date of Report | 2017-11-14 |
| Date Mfgr Received | 2017-11-14 |
| Date Added to Maude | 2017-12-05 |
| 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 | MRS. BIANCA PRIES |
| Manufacturer Street | 1 UNIVERSITY AVENUE |
| Manufacturer City | MACQUARIE UNIVERSITY, NSW 2109 |
| Manufacturer Country | AS |
| Manufacturer Postal | 2109 |
| Manufacturer G1 | COCHLEAR BONE ANCHORED SOLUTIONS AB |
| Manufacturer Street | KONSTRUKTIONSV PO BOX 82 |
| Manufacturer City | M 43533 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 43533 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COCHLEAR? VISTAFIX? VXI300 IMPLANT 3MM |
| Generic Name | COCHLEAR BAHA VISTAFIX SYSTEM |
| Product Code | FZE |
| Date Received | 2017-12-05 |
| Model Number | 93100 |
| Catalog Number | 93100 |
| Lot Number | 167321 |
| Device Expiration Date | 2019-11-30 |
| 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 | 2017-12-05 |