MAUDE Adverse Event Report: 3M HEALTH CARE 3M CLARITY ALIGNERS; ALIGNER, SEQUENTIAL

Model Number	359-455
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cellulitis (1768); Laceration(s) (1946)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.3m will continue to monitor.
Event or Problem Description
A three-day hospitalization for submental cellulitis of the neck was reported that resulted during orthodontic treatment with 3m clarity aligners.Prior to the hospitalization, the aligners were trimmed due to alleged cutting of the tongue and roof of the mouth.Treatment included administration of an intravenous antibiotic (unspecified) and oral clindamycin upon discharge.Discharge instructed to complete the course of antibiotics as prescribed, to apply warm compresses to the affected area.
Additional Manufacturer Narrative
H10: updated b5 to include additional information received.
Event or Problem Description
A three-day hospitalization for submental cellulitis of the neck was reported that resulted during orthodontic treatment with 3m clarity aligners.Prior to the hospitalization, the aligners were trimmed due to alleged cutting of the tongue and roof of the mouth.Treatment included administration of an intravenous antibiotic (unspecified) and oral clindamycin upon discharge.Discharge instructed to complete the course of antibiotics as prescribed, to apply warm compresses to the affected area.Additional information received noted that the cellulitis was caused by an insect bite.The patient is continuing orthodontic treatment with 3m clarity aligners.

• Brand Name: 3M CLARITY ALIGNERS
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 12067947
• Report Number: 2020467-2021-00001
• Device Sequence Number: 3959865
• Product Code: NXC
• UDI-Device Identifier: 00652221290878
• UDI-Public: 00652221290878
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K211190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/12/2024
• Device Model Number: 359-455
• Device Catalogue Number: 359-455
• Device Lot Number: WMFLY02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 42 YR