MAUDE Adverse Event Report: HYDROGUM 5 ALGINATE; MATERIAL, IMPRESSION

Catalog Number C302070

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling/ Edema (4577)

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.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

Patient reported that after having an impression of her lower teeth with hydrogum impression material, for the next two days she had a rash around the inside of her lip and had about 5 small blisters about 1mm in diameter.3 on the left hand side and 2 on the right hand side all on the inside of her lip.These burst after 2 days and resolved.The rash also disappeared after two days.Patient was seen 10 days after the impression was taken and her lip had returned to normal and there appeared to be no abnormalities.

Manufacturer Narrative

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

• Brand Name: HYDROGUM 5 ALGINATE
• Type of Device: MATERIAL, IMPRESSION
• MDR Report Key: 11899189
• MDR Text Key: 253128887
• Report Number: 9614794-2021-00001
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• PMA/PMN Number: K051424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C302070
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other