inforMED
InjuryECO

FORSUS FATIGUE RESISTANT DEVICE SPRING MODULE

Received May 12, 2006 · Event occurred Jan 17, 2006

Report 2020467-2006-00004 · MDR key 714408

Device

Generic name

Orthodontic Spring

Manufacturer

3m Unitek

Model number

NA

Catalog number

885-100

Lot number

UNK

Product problems

  • Unknown (for use when the device problem is not known)

Patient

13 YR

  • Unspecified Infection
  • Irritation
  • Therapeutic Response, Increased
  • Ulcer
  • Treatment with medication(s)

Narrative

Description of Event or Problem

DUE TO IRRITATION FROM DEVICE, PT DEVELOPED AN INTRAORAL ULCER BECAME INFECTED. PER ORTHODONTIST, AN EMERGENCY ROOM PHYSICIAN PRESCRIBED AN ANTIBIOTIC (AMOXICILLIN) FOR THE INFECTION AND ORTHODONTIST PRESCRIBED MARY'S MAGIC MOUTHWASH. ORTHODONTIST STATED THAT THE INTRAORAL ULCER AND INFECTION HAD COMPLETELY RESOLVED WITHIN A COUBLE WEEKS AND THAT PT HAS CONTINUED WITH THE ORTHODONTIC TREATMENT.