MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ CLARITY¿ ALIGNERS FLEX, SINGLE-ARCH ALIGNER; ALIGNER, SEQUENTIAL

Model Number 70000916729

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)

Event Date 01/17/2023

Event Type  Injury  

Event Description

Intraoral itchiness and swelling of the lips were reported after use of a 3m clarity aligner flex, single-arch aligner.The symptoms began the same day in the evening after an aligner was worn.Attachments were placed at the orthodontic clinic earlier that day and no symptoms had occurred when the patient had left the orthodontic office.The patient went to the emergency room, an epinephrine injection was administered, the patient spent the night for observation and was discharged.The attachments were removed on the date of discharge and no further symptoms occurred.

Manufacturer Narrative

No information was provided.The device was not returned for evaluation.3m will continue to monitor.

• Brand Name: 3M¿ CLARITY¿ ALIGNERS FLEX, SINGLE-ARCH ALIGNER
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M UNITEK CORPORATION; 2724 south peck rd.; monrovia CA 91016 5097
• Manufacturer Contact: kristin totushek ; 3m center, bldg. 275-2w-08; 2510 conway ave; st. paul, MN 55144-1000 ; 6517366117
• MDR Report Key: 16287577
• MDR Text Key: 308705950
• Report Number: 2020467-2023-00001
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00652221236609
• UDI-Public: 00652221236609
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K211190
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 70000916729
• Device Catalogue Number: 359-212
• Device Lot Number: NDRSH03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female