GLUMA DESENSITIZER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-10 for GLUMA DESENSITIZER manufactured by Unk.

Event Text Entries

[133318512] On (b)(6) 2018 the dentist removed a temporary crown and used gluma desensitizer. The assistant tried to use gauze to block the chemical from touching my skin and i was told the gluma sometimes irritate skin. The permanent crown was not correct, so the dentist had her prepare another temporary crown. The next morning, i had swelling of my tongue and blisters along and under my tongue on the lower left side of my mouth. The swelling lasted for three days and the blisters lasted one week. On (b)(6) 2019 gluma was used again during the preparation for the permanent crown with no safeguards for the chemical application. The next morning, i experienced tongue, face, lip swelling, rash and blisters on my tongue, as well as the left side of my mouth. I was treated for a chemical burn and drug allergy at a local er and prescribed steroids. Date the person first started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2019; administered by dentist.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5083075
• MDR Report Key: 8239918
• Date Received: 2019-01-10
• Date of Report: 2019-01-08
• Date of Event: 2019-01-02
• Date Added to Maude: 2019-01-11
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: GLUMA DESENSITIZER
• Generic Name: AGENT, TOOTH BONDING, RESIN
• Product Code: KLE
• Date Received: 2019-01-10
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-01-10