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 05/10/2023

Event Type  Injury  

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 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.

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.
• 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: 17098119
• MDR Text Key: 316874036
• Report Number: 9614794-2023-00008
• 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,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 06/05/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2023
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: ORAL AMOXICILLIN FOR 2 DAYS