InjuryECO
AFORSUS FATIGUE RESISTANCE DEVICE SPRINT MODEL
Received Feb 16, 2009 · Event occurred Aug 29, 2008
Report 2020467-2009-00001 · MDR key 1315670
Device
Product problems
- Device, removal of (non-implant)
Patient
9 YR
- Unspecified Infection
- Irritation
- Improved patient condition
- Ulcer
- Therapy/non-surgical treatment, additional
- Treatment with medication(s)
Narrative
Description of Event or Problem
DUE TO IRRITATION FROM THE DEVICE, PATIENT DEVELOPED AN INTRAORAL ULCER. ORTHODONTIST PRESCRIBED SALT WATER RINSES AND AN ANTIBIOTIC (ERYTHROMYCIN) FOR THE PATIENT. THE DEVICE WAS REMOVED AND PATIENT HAS RECOVERED FROM THE INFECTION.