MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PRO ROOT MTA 4X0.5GR WHITE; RESIN, ROOT CANAL FILLING

Catalog Number	A040500000300
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/06/2024
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 was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.Product discarded, nothing being returned and lot number unknown.
Event or Problem Description
In this event it is reported that a patient experienced an allergic reaction to the pro root mta 4x0.5gr white that was used in a procedure.The patient developed the reaction after returning home from the procedure.Patient symptoms consisted of erythema and throat discomfort.The patient was admitted to the hospital where the removal of the pro root mta 4x0.5gr white from the root canal was done.

• Brand Name: PRO ROOT MTA 4X0.5GR WHITE
• Common Device Name: RESIN, ROOT CANAL FILLING
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20219683
• Report Number: 2320721-2024-00058
• Device Sequence Number: 17973892
• Product Code: KIF
• UDI-Device Identifier: D716PROROOT5W1
• UDI-Public: D716PROROOT5W1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/14/2024

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: A040500000300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/09/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 09/14/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 85 KG