MAUDE Adverse Event Report: DENTSPLY LLC CALIBRA VEN TRY-IN 1.8GM MD RF; CEMENT, DENTAL

Model Number	607301
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Malfunction
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 has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that calibra ven try-in 1.8gm lt rf that was used allegedly caused a irriatiation reaction to a patient.No injury reported.Further information requested.
Additional Manufacturer Narrative
Investigation: product was expired five years ago.Not able to investigate.Product expired in 2018.Complaint was submitted in 2023.No defect proven.

• Brand Name: CALIBRA VEN TRY-IN 1.8GM MD RF
• Common Device Name: 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: 17194487
• Report Number: 2515379-2023-00083
• Device Sequence Number: 12229810
• Product Code: EMA
• UDI-Device Identifier: D0026073011
• UDI-Public: D0026073011
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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 Model Number: 607301
• Device Catalogue Number: 607302
• Device Lot Number: 160930
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/22/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown