inforMED
InjuryECO

FORSUS FATIGUE RESISTANT DEVICE WITH DIRECT PUSH ROD

Received Apr 3, 2002 · Event occurred Mar 1, 2002

Report 2020467-2002-00002 · MDR key 386955

Device

Generic name

Orthodontic Spring

Manufacturer

3m Unitek

Model number

NA

Catalog number

885-121

Lot number

UNK

Product problems

  • Reaction

Patient

15 YR

  • Unspecified Infection
  • Irritation
  • Ulcer
  • Therapy/non-surgical treatment, aborted/stopped
  • Treatment with medication(s)

Narrative

Description of Event or Problem

ORTHODONTIST REPORTED THAT DUE TO IRRITATION FROM DEVICE, PT DEVELOPED AN INTRAORAL ULCER WHICH BECAME INFECTED. A PHYSICIAN AT AN URGENT CARE CENTER PRESCRIBED AN ANTIBIOTIC (ERTHROMYCIN) TO PT FOR THE INFECTION. ORTHODONTIST REMOVED THE DEVICE FROM PT'S MOUTH AND THE ULCER HAS HEALED COMPLETELY. ORTHODONTIST REPORTED THAT PT IS DOING FINE AND HAS CONTINUED WITH ORTHODONTIC TREATMENT.