MAUDE Adverse Event Report: KULZER GMBH-HQ GLUMA DESENSITIZER; AGENT, TOOTH BONDING, RESIN, PRODUCT CODE: KLE

Catalog Number 65872354

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urticaria (2278)

Event Date 04/28/2022

Event Type  Injury  

Event Description

Patient experienced hives on trunk and limbs of the body after gluma desensitizer was administered.Patient sought treatment from a dermatologist.An allergy test has not been conducted at this time that we are aware of.The dermatologist considers this issue less relevant to the gluma desensitizer, however, out of an abundance of caution, this is reportable.

Manufacturer Narrative

This incident is reportable according to 21 cfr 803.The fda defines this as a serious injury (21 cfr sec.803.3) as the dermatologist reported the patient having an allergic type reaction.The incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.Patient suffered hive like rash on the trunk and limbs of the body after gluma desensitizer was applied.It is stated in the instructions for use that gluma desensitizer can cause irritation, chemical burns and hypersensitivity.Must not be used if the patient has hypersensitivity like rashes and skin inflammation to any of the ingredients contained in gluma desensitizer.An allergy test has not been completed at this time and it is unknown if an allergy test will be conducted.We cannot determine if our product did or did not cause this allergic type reaction, therefore we will report this incident out of an abundance of caution.Manufacturer narrative: gluma desensitizer is not yet the proven root cause for the triggered allergic reaction.

Manufacturer Narrative

*6/13/2022 follow up information: according to confirmation by the dermatologist, the patient stated that the symptoms appeared 2 -3 months after treatment with gluma desensitizer.The dermatologist concluded that this incident had nothing to do with gluma desensitizer.Therefore, there is no need to report to the authorities.

Event Description

Patient experienced hives on trunk and limbs of the body after gluma desensitizer was administered.Patient sought treatment from a dermatologist.An allergy test has not been conducted at this time that we are aware of.The dermatologist considers this issue less relevent to the gluma desensitizer, however, out of an abundance of caution, this is reportable.*6/13/2022 follow up information: according to confirmation by the dermatologist, the patient stated that the symptoms appeared 2 -3 months after treatment with gluma desensitizer.The dermatologist concluded that this incident had nothing to do with gluma desensitizer.Therefore, there is no need to report to the authorities.*.

• Brand Name: GLUMA DESENSITIZER
• Type of Device: AGENT, TOOTH BONDING, RESIN, PRODUCT CODE: KLE
• Manufacturer (Section D): KULZER GMBH-HQ; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• MDR Report Key: 14497061
• MDR Text Key: 294160236
• Report Number: 1821514-2022-00002
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2022,06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 65872354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2022
• Distributor Facility Aware Date: 04/28/2022
• Event Location: Other
• Date Report to Manufacturer: 05/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other