MAUDE Adverse Event Report: DENTSPLY DETREY GMBH SUREFIL ONE ECO A2; CEMENT, DENTAL

Catalog Number 60300302

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

In this event it is reported that surefil one eco a2, when activating or shaking the capsule, the two components powder and liquid did not mix.Only liquid came out of the capsule.In the process, some of it entered the patient's mouth.The oral mucosa is affected.The dentist applied a wound ointment following the incident.The outcome of this event is unknown as of this mdr.Further information is being requested.

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 was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Manufacturer Narrative

Investigation results: complaint material was discarded and lot is not known - so no investigations can be conducted! upon request, a batch was communicated and two activated capsules were sent in.Customer sent two activated capsule, therefore retain was tested.The retain product can be mixed and processed as usual.Working time is in specification.Complaint cannot be confirmed.

• Brand Name: SUREFIL ONE ECO A2
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer (Section G): DENTSPLY DETREY GMBH; detrey strasse 1; konstanz baden-wurttemberg 78467 ; GM 78467
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 16427511
• MDR Text Key: 310060530
• Report Number: 8010638-2023-00019
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K192530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 60300302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/16/2023
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1