MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC AH PLUS BIOCERAMIC SEALER STARTER KIT; RESIN, ROOT CANAL FILLING

Catalog Number AHPBIOSEAL

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/16/2022

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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that ahpbioseal may have caused allergic reaction of swelling to the patient.Outcome of patient status is unknown of this mdr and additional information is requested.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.

• Brand Name: AH PLUS BIOCERAMIC SEALER STARTER KIT
• Type of Device: 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 14429572
• MDR Text Key: 291942139
• Report Number: 2320721-2022-00160
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960548
• 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: 08/16/2022

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?: Yes
• Device Catalogue Number: AHPBIOSEAL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/16/2022
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1