MAUDE Adverse Event Report: ZHERMACK S.P.A. NEOCOLLOID ALGINATE; MATERIAL, IMPRESSION

Catalog Number C302205

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/06/2021

Event Type  Injury  

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.Multiple unsuccessful attempts were made to obtain the device for evaluation.A dhr review was conducted with no discrepancies noted.

Event Description

It was reported that a patient experienced an allergic reaction to neocolloid ll busta impression material.The patient rinsed with saline and followed the doctor's instructions and after an hour the patient symptoms subsided.

• Brand Name: NEOCOLLOID ALGINATE
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): ZHERMACK S.P.A.; via bovazecchino, 100; badia polesine, rovigo 45021 ; IT 45021
• Manufacturer (Section G): ZHERMACK S.P.A.; via bovazecchino, 100; badia polesine, rovigo 45021 ; IT 45021
• Manufacturer Contact: joleta ness ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 11943739
• MDR Text Key: 264090899
• Report Number: 9614794-2021-00002
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• PMA/PMN Number: K981091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 06/04/2021

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 Operator: Health Professional
• Device Catalogue Number: C302205
• Device Lot Number: 0000355636
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR