MAUDE Adverse Event Report: ZHERMACK S.P.A. TROPICALGIN ALGINATO BUSTA 453G.; MATERIAL, IMPRESSION

Catalog Number C302240

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

In this event it is reported that a patient experienced an allergic reaction during use of tropicalgin impression material.Outcome of this event is unknown as of this mdr.

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.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Manufacturer Narrative

Investigation results: no anomaly found in the dhr on the merits of what was complained of; the production's report has been controlled and the correct flavours were used.The retain has been tested and the sample has his characteristic smell.The sds related to the flavors used have no indication about the presence of allergic substances.No defect proven/no failure found.

• Brand Name: TROPICALGIN ALGINATO BUSTA 453G.
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): ZHERMACK S.P.A.; via bovazecchino, 100; badia polesine (ro) rovigo 45021 ; IT 45021
• Manufacturer (Section G): ZHERMACK S.P.A.; via bovazecchino, 100; badia polesine (ro) rovigo 45021 ; IT 45021
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 15575460
• MDR Text Key: 301521428
• Report Number: 9614794-2022-00006
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• PMA/PMN Number: K043131
• 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: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: C302240
• Device Lot Number: 390014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/26/2022
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other