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

Catalog Number	C302025
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
In this event it is reported that a patient had a reaction to hydrogum ll busta 500 g.That caused blisters.

• Brand Name: HYDROGUM 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20246571
• Report Number: 9614794-2024-00002
• Device Sequence Number: 7282734
• Product Code: ELW
• UDI-Device Identifier: EZHIC3020250
• UDI-Public: EZHIC3020250
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 09/18/2024

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: C302025
• Device Lot Number: 438119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/17/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 09/18/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female