MAUDE Adverse Event Report: DENTSPLY LLC CALIBRA UNIV CEM SYR REF TRAN; CEMENT, DENTAL

Catalog Number 607405

Device Problems Patient-Device Incompatibility (2682); Output Problem (3005); Unexpected Color (4055)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  malfunction  

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.Request for additional information has been requested and will be submitted as it becomes available.

Event Description

In this event it has been reported that calibra universal cem syringe contents is yellow and causing sensitivity.Injury is unknown at the time of this mdr, additional information has been requested.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Event Description

Multiple unsuccessful attempts were made to obtain the patient outcome.

• Brand Name: CALIBRA UNIV CEM SYR REF TRAN
• 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: 13623055
• MDR Text Key: 289074692
• Report Number: 2515379-2022-00040
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 607405
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/11/2022
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1