InjuryFZE
ASKU
Received May 11, 2026
Report 6000034-2026-01772 · MDR key 25134067
Device
Generic name
Cochlear Baha Vistafix System
Manufacturer
Cochlear Bone Anchored Solutions AbModel number
ASKUCatalog number
ASKU
Lot number
ASKU
Product problems
- Patient Device Interaction Problem
Patient
NA · Unknown
- Impaired Healing
Narrative
Description of Event or Problem
PER THE CLINIC, THE PATIENT DEVELOPED A SKIN OVERGROWTH. THE PATIENT SUBSEQUENTLY UNDERWENT A SKIN REVISION PROCEDURE FOR RESECTION OF THE EXCESS SKIN (DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.