MAUDE Adverse Event Report: DENTSPLY INDUSTRIA E COMERCIO LTDA JELTRATE PLUS ENV 454 GR NOVO; MATERIAL, IMPRESSION

Catalog Number 05130180000

Device Problem Patient-Device Incompatibility (2682)

Patient Problem 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.Investigation summary:  despite the claim that the product caused an allergic reaction in the customer after use, the potential residual risk of allergic reaction in persons sensitive to any of the components of the formulation is known and established by the company, therefore the residual risk statement is on the label and instruction for use of the medical device.Dentsply sirona was aware of the event and contacted the clinic using the jeltrate plus alginate to try to reach the affected patient to collect detailed information about his health condition, but the response was negative, claiming that the patient is in good health and not willing to provide further information about the event.Without the return of the reclaimed sample, we have so far evaluated the retained sample of the reclaimed lot, which complies with the internal requirements.Additionally, all production documentation (dhr) was evaluated and no discrepancies were found during the manufacturing process of this lot.This lot had (b)(4) units produced in february 2022 with only 1 claim containing the quantity of 1 unit claimed, which represents 0.10% of the total produced.Extrapolating the analysis to the period from 2016 to 2022, the sales volume was 213,013 units, this percentage drops to 0.00046%, which historically demonstrates the low potential for allergic reactions that the product can cause.All complaint data from the complaint system was evaluated and the only notification of allergic reaction known to dentsply other than the one related to jeltrate plus was for avagel (alginate with similarity of use) which occurred in 2016 and actions were established after the reported event.However, the complaint process will continue to be reviewed monthly through the product surveillance committee (psc) meetings and if there is a trend of complaints of this product with the allegation of this adverse event, new actions will be defined to monitor, control and mitigate this type of event.

Event Description

In this event it is reported that jeltrate plus allegedly cause an allergic reaction of swelling in the mouth after use.

• Brand Name: JELTRATE PLUS ENV 454 GR NOVO
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): DENTSPLY INDUSTRIA E COMERCIO LTDA; rua jose francisco de souza 19; pirassununga sao paulo 13633 -412; BR 13633-412
• Manufacturer (Section G): DENTSPLY INDUSTRIA E COMERCIO LTDA; rua jose francisco de souza 19; pirassununga sao paulo 13633 -412; BR 13633-412
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 15301517
• MDR Text Key: 298691876
• Report Number: 8040288-2022-00001
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K952614
• 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
• Report Date: 08/26/2022

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 Catalogue Number: 05130180000
• Device Lot Number: 379438O
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/19/2022
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1