CREATURES OF THE SEA
Received Nov 26, 2024 · Event occurred Aug 20, 2024
Report 20782233 · MDR key 20782233
Device
Generic name
Band, Elastic, Orthodontic
Manufacturer
Ortho Technology, Inc.Model number
500-303LFLot 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 I NOTIFIED THE SAFETY COACH AT THE OR DESK OF EACH SITUATION TO SEE IF THE RUBBER BANDS MAY BE OUTDATED.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.