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

Lot Number	801177
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional 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 results are not available as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
It was reported that a patient experienced an allergic reaction to the use of integrity multicure.The doctor reported the patient had red patches.
Additional 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 & BRIDGE MATERIAL
• Common Device Name: CROWN AND BRIDGE, TEMPORARY, RESIN
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• MDR Report Key: 10731616
• Report Number: 2515379-2020-00008
• Device Sequence Number: 3663838
• Product Code: EBG
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Lot Number: 801177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 07/22/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR