MAUDE Adverse Event Report: HERAEUS KULZER GMBH GLUMA DESENSITIZER 1X5 ML; AGENT, TOOTH BONDING, RESIN

Catalog Number 65872354

Device Problems Labelling, Instructions for Use or Training Problem (1318); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Ulceration (2116); Burning Sensation (2146)

Event Date 05/20/2015

Event Type  Injury  

Event Description

Confidential call from female patient from (b)(6).Called for ingredients list for gluma desensitizer.Patient stated she has multiple allergies and sensitivities including latex, propylene glycol and bleached cotton.She had bridgework prepped two weeks ago and the dds used gd on her, then again yesterday with the bridge delivery.She had white spots and discomfort intraorally after the first application.Patient said she could feel burning sensation as they placed gd yesterday, and has swollen and burned tongue today.She let the office know that she was experiencing problems and was told to take benadryl.The dds, who she describes as holistic, told her gluma was derived from fish.I asked patient permission to speak to her dds, and she agreed.I gave her my direct line and schedule so that he may call in and i can review dfu with him.This is a serious injury (as defined in 21 cfr section 803.3) as the patient reported having an adverse reaction and required intervention to prevent potential permanent harm to a body structure.Because the malfunction allegation could not be confirmed, the cause of the adverse reaction could not be determined.This incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.

Manufacturer Narrative

As allowed by exemption# (b)(4) (the importer) is submitting the report on behalf of (b)(4) (the manufacturer).Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution.Narrative for method/results/conclusion codes evaluation summary directions for use indicate rubber dam use is required.The office used no isolation and did not rinse patient.Device not returned.

• Brand Name: GLUMA DESENSITIZER 1X5 ML
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-61 273; GM D-61273
• Manufacturer (Section G): HERAEUS KULZER, LLC; 300 heraeus way; south bend IN 46614 251
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 4799386
• MDR Text Key: 5881356
• Report Number: 9610902-2015-00012
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• PMA/PMN Number: K962812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2015

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: Dentist
• Device Catalogue Number: 65872354
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/21/2015
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention