MAUDE Adverse Event Report: ZHERMACK S.P.A. NEOCOLLOID LL BUSTA 500 G.; MATERIAL, IMPRESSION

Catalog Number C302205

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/05/2024

Event Type  Injury  

Event Description

In this event it is reported that neocolloid ll busta 500 g.Was used in a full mouth impression that was taken using the product in the oral cavity.The next day, the patient reported that their gums were swollen and uncomfortable.After oral examination, it was found that redness, swelling, and white punctate plaques were present in the mucosal folds of bilateral maxillary nodules.Local iodine glycerin was applied and mouthwash was used to rinse the mouth.The patient was advised to observe.Event cause analysis description mentioned by doctor: alginate impression material has a stimulating effect on mucous membranes.

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.

• Brand Name: NEOCOLLOID LL BUSTA 500 G.
• 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: 19048993
• MDR Text Key: 339433211
• Report Number: 9614794-2024-00001
• Device Sequence Number: 1
• Product Code: ELW
• UDI-Device Identifier: EZHIC3022050
• UDI-Public: EZHIC3022050
• 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
• Report Date: 04/05/2024

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: C302205
• Device Lot Number: 0000423900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/26/2024
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/05/2024
• Date Device Manufactured: 06/09/2023
• Type of Device Usage: A
• Patient Sequence Number: 1