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

Catalog Number	C302205
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Investigation results: the device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are: retain: the test on the retained sample shows no defect or abnormalities.Failure mode: patient reaction.Root cause: no defect proven.Conclusion code: no failure found.

• Brand Name: NEOCOLLOID LL BUSTA 500 G.
• Common Device Name: 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
• Report Number: 9614794-2024-00001
• Device Sequence Number: 12898741
• Product Code: ELW
• UDI-Device Identifier: EZHIC3022050
• UDI-Public: EZHIC3022050
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown