MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. SURESMILE RETAINER; ALIGNER, SEQUENTIAL

Catalog Number ASSY-500015

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

While it is unknown if the device used in this case caused or contributed to the patient¿s symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device was not returned for evaluation.However, the serial/ lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Event Description

In this event it is reported that a patient experienced allergic reaction to suresmile retainer.Patient symptoms included swelling and stinging sensation on the lips.The patient does have a known allergy to latex, however the dental office reports use of vinyl, not latex, examination gloves.To date, there have not been any additional medical treatments reported related to this incident.

Manufacturer Narrative

Dhr evaluation: we reviewed the dhr for this (b)(6).Qty.(b)(4) items assy-500015 (retainers), were packaged by of first shift by auto packing operation on october 31, 2023, manufacturing supercell sc2, equipment pua-03.The sales order was inspected and met with the acceptance criteria provided by qa.Other incoming inspection.We reviewed the incoming inspection record for the material used to manufacture this (b)(6).· raw material: (b)(4) / lot# 07334479 / qty.Received = (b)(4) pcs, inspection date: september 01, 2023.· the material was found to be acceptable for use in the manufacture of the sure smile product.Evidence: - in the evidence provided (allergic reaction checklist) the patient declares that he does not suffer from allergies.- the patient was not tested to detect allergies to the product.- symptoms: swelling of lips.Some sting sensation but not painful.- the evidence provided showed the alleged event (swelling of lips.

• Brand Name: SURESMILE RETAINER
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 2350 campbell creek blvd. suit; richardson TX 75082
• Manufacturer (Section G): DENTSPLY SIRONA ORTHODONTICS INC.; 2350 campbell creek blvd. suit; richardson TX 75082
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18530073
• MDR Text Key: 333065652
• Report Number: 1649995-2024-00001
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00856379007023
• UDI-Public: 00856379007023
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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
• Device Catalogue Number: ASSY-500015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/11/2024
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1