MAUDE Adverse Event Report: INTEGRITY MULTI-CURE TEMPORARY CROWN AND BRIDGE MATERIAL; CROWN AND BRIDGE, TEMPORARY, RESIN

Catalog Number 666640

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Blister (4537); Swelling/ Edema (4577)

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 a patient had a reaction to integrity multicure.The patient had temporaries made with integrity multicure and left with swelling and blistering on her upper lip.She was unaware of previous allergies and was given mouthwash and medrol to treat the symptoms.The symptoms seem to subside after using the mouthwash and medrol.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.A dhr review was conducted with no discrepancies noted.

• Brand Name: INTEGRITY MULTI-CURE TEMPORARY CROWN AND BRIDGE MATERIAL
• Type of Device: CROWN AND BRIDGE, TEMPORARY, RESIN
• MDR Report Key: 12207474
• MDR Text Key: 262876310
• Report Number: 2515379-2021-00014
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• PMA/PMN Number: K101710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 666640
• Device Lot Number: 180119
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other