MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. ESSIX A+ PLASTIC .040 X 5" PETG VACUUM SQUARE 100PK; MOUTHGUARD, PRESCRIPTION

Catalog Number	10045
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Additional 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 is available for evaluation.Though, has not been returned as of this report.Evaluation results will be submitted, as they become available.
Event or Problem Description
In this event, it is reported, that a patient experienced an allergic reaction from wearing a nightguard with essix a+ plastic, 040 x 5" petg vacuum square 100pk.Reportedly, they needed hospital care.Further information requested.
Additional Manufacturer Narrative
Dhr 11-18-2024: dhr for item# 10045 essix a+ plastic.040 x 5" petg vacuum square 100pk lot# 07904480 has been pulled, reviewed, and attached to this case.Dhr review did not identify any issues during the cutting, sealing and packaging production order, with all inspections performed and deemed acceptable by the operator(s) and quality as per 0290-wi-7.5-50-03 and 0290-ip-7.5-50-05.The receiving documentation/quality inspection for item# a+040-lg lot# 228372 (large sheets used to cut/package item# 10045 lot# 07904480) has also been pulled and attached to this case.Receiving inspection did not identify any issues with receiving, with all inspections performed and deemed acceptable by quality as per 0290-ip-7.5-80-01.(nwv).Retain: 11-18-2024: final product retains are not kept as per normal procedure, retains for item# 10045 lot# 07904480 which were bubbling testing results and a foil bag sealed with 2 sheets of plastic are kept for bubbling plastic investigations only, have already been discarded as per 0290-wi-8.2-07 which states retention samples must be maintained for a minimum of six months (produced 12-2023).(nwv).Failure mode - allergic reaction.Root cause - no defect proven.Conclusion code - no failure found.

• Brand Name: ESSIX A+ PLASTIC .040 X 5" PETG VACUUM SQUARE 100PK
• Common Device Name: MOUTHGUARD, PRESCRIPTION
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 7290 26th court east; sarasota FL 34243
• Manufacturer (Section G): DENTSPLY SIRONA ORTHODONTICS INC.; 7290 26th court east; sarasota FL 34243
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20673025
• Report Number: 1036212-2024-00002
• Device Sequence Number: 15511658
• Product Code: MQC
• UDI-Device Identifier: D746100451
• UDI-Public: D746100451
• Combination Product (Y/N): N
• PMA/510(K) Number: K062828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 10045
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/08/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown