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	05/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr 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 neocolloid ll busta 500 g.During use patient developed mucosal swelling after using the product to take impression.A saline gargle was given and symptoms improved.
Additional Manufacturer Narrative
Adding udi # - udi # (b)(4).This is a follow up report to report this information.Retain investigation: no defect has been found.The retained sample is compliant for every specification investigated.Dhr: no abnormalities found in dhr.Checked receipts without detecting anomalies.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: 17098119
• Report Number: 9614794-2023-00008
• Device Sequence Number: 1894720
• 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): 08/09/2023

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: C302205
• Device Lot Number: 0000412909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/05/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ORAL AMOXICILLIN FOR 2 DAYS
• Patient Sex: Unknown