inforMED
MalfunctionECI

CREATURES OF THE SEA

Received Nov 26, 2024 · Event occurred Aug 20, 2024

Report 20782233 · MDR key 20782233

Device

Generic name

Band, Elastic, Orthodontic

Model number

500-303LF

Lot number

20210820

Patient

NA · Prefer Not To Disclose

  • Discomfort
  • Discomfort

Narrative

Description of Event or Problem

IN THE LAST 8 DAYS, I HAVE ADMITTED 3 PATIENTS INTO THE PACU FOLLOWING GENIOPLASTY SURGERY. IN EACH CASE THE PATIENT HAD RUBBER BANDS APPLIED TO THE WIRE BANDS ON THEIR TEETH TO PROVIDE STABILITY AND TO PREVENT THE OPENING OF THE MOUTH. IN EACH SITUATION THE RUBBER BANDS HAVE BROKEN WITHIN AN HOUR OF PATIENT¿S ARRIVAL IN PACU. IN THE FIRST PATIENT, 6 RUBBER BANDS BROKE. THE SECOND PATIENT HAD 2 RUBBER BANDS BREAK. THE THIRD PATIENT HAD 1 RUBBER BAND BREAK. I HAD TO REMOVE THE BROKEN BANDS WITH FORCEPS. IN EACH SITUATION THE PATIENT WAS BEING COMPLIANT AND NOT DOING ANYTHING TO CAUSE THE BANDS TO BREAK. NEW BANDS HAD TO BE APPLIED BY OMS (ORAL MAXILLOFACIAL SURGERY) RESIDENT WHICH CAUSED EXTRA DISCOMFORT TO THE PATIENT. I NOTIFIED THE SAFETY COACH AT THE OR DESK OF EACH SITUATION TO SEE IF THE RUBBER BANDS MAY BE OUTDATED. THE PACKAGES FOR THE BANDS WERE CHECKED AND NOT EXPIRED.