MAUDE Adverse Event Report: ZHERMACK S.P.A. ELITE HD+PUTTY NORMAL SET 250+250ML; MATERIAL, IMPRESSION

Catalog Number C203000

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Insufficient Information (4580)

Event Date 11/15/2022

Event Type  Injury  

Event Description

In this event it is reported that elite hd+putty soft normalset 250ml+250ml was used making the impression material for the patient, it was found that the patient had severe nausea and vomiting.Doctor immediately stopped making the impression.Event cause analysis description mentioned by doctor: may be related to the patient's allergy to this product, may also be related to the patient's pharyngitis.Additional information for this event has been 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.Investigation results from retained product: all measured characteristics meet warranty specifications.Test carried out by hand mixing weighed components.No defect proven.Conclusion: no failure found.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.

Manufacturer Narrative

Investigation results: investigation type - retain: all measured characteristics meet warranty specifications.Test carried out by hand mixing weighed components.Root cause: no defect proven.Conclustion: no failure found.

• Brand Name: ELITE HD+PUTTY NORMAL SET 250+250ML
• 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: 16016822
• MDR Text Key: 305830026
• Report Number: 9614794-2022-00007
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/04/2023

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 Catalogue Number: C203000
• Device Lot Number: 356914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/27/2022
• Initial Date Manufacturer Received: 11/27/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 11/27/2022
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2020
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female