MAUDE Adverse Event Report: DENTSPLY CAULK INTEGRITY TEMPGRIP; CEMENT, DENTAL

Catalog Number 666450

Device Problems Contamination (1120); Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Reaction (2414)

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

It was reported that a patient experienced a rash after the use of integrity tempgrip.The dentist reported that they had used integrity tempgrip in the past on this patient, and there was never any reaction.The patient is a throat cancer survivor and is currently getting injections for saliva production and is also using chlorohexidine rinse.The dentist also reported that this patient is prone to thrush and that their nightguard was very dirty and causing the patient to have issues.The patient continued with the rinse and the rash is mostly gone.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.Retained product was evaluated and found to be within specification.

• Brand Name: INTEGRITY TEMPGRIP
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• MDR Report Key: 9550244
• MDR Text Key: 183906217
• Report Number: 2515379-2019-00036
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• PMA/PMN Number: K973201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 666450
• Device Lot Number: 00026736
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other