MAUDE Adverse Event Report: DENTSPLY LLC TOPEX PROPHY PASTE; AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Catalog Number ASKU

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 and the lot number was not provided for retained-product testing and/or dhr review.

Event Description

While using topex prophy paste (flavor unknown) on a patient, during her cleaning she had a severe allergic reaction.She has a alpha gal allergy to any mammal ingredients including dairy.Her dental hygienist was notified but having alpha gal (mammal allergy) her reaction was delayed.She had a cleaning 3-4pm and woke up 5am the next morning covered in hives.She was trying to trouble shoot what could have caused it, beside suspecting a recent change in a prescription drug started almost 2 weeks prior.The event outcome is unknown as of this mdr evaluation.

• Brand Name: TOPEX PROPHY PASTE
• Type of Device: AGENT, POLISHING, ABRASIVE, ORAL CAVITY
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: joleta ness ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 11853037
• MDR Text Key: 251665532
• Report Number: 2424472-2021-00027
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other