MAUDE Adverse Event Report: DENTSPLY LLC INTEGRITY TEMP GRIP REFILL PK; CEMENT, DENTAL

Catalog Number 666450

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

In this event it was reported that a patient may have experienced an adverse reaction after undergoing a dental procedure that involved the use of integrity temp grip.The patient presented with ulcerations and peeling look to gingiva, burning sensation, and pain and has an allergy to acrylates and sulfa drugs.Doctor reports that patient was taking benadryl and doctor prescribed prednisone.

• Brand Name: INTEGRITY TEMP GRIP REFILL PK
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 16511858
• MDR Text Key: 310955584
• Report Number: 2515379-2023-00064
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/09/2023

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: 666450
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/07/2023
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/09/2023
• Type of Device Usage: A
• Patient Sequence Number: 1