MAUDE Adverse Event Report: ZHERMACK S.P.A. TROPICALGIN ALGINATE; MATERIAL, IMPRESSION

Catalog Number C302240

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

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.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

It was reported that a patient experienced an allergic reaction after the use of tropicalgin impression material.Additional information has been requested, but is not yet available.

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.Multiple unsuccessful attempts were made to obtain the patient outcome.

• Brand Name: TROPICALGIN ALGINATE
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): ZHERMACK S.P.A.; via bovazecchino, 100; badia polesine, 45021 ; IT 45021
• MDR Report Key: 8219660
• MDR Text Key: 132150440
• Report Number: 9614794-2018-00005
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C302240
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 02/15/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other