MAUDE Adverse Event Report: HERAEUS KULZER GMBH GLUMA DESENSITIZER 1 X 5 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 Problem Ulceration (2116)

Event Date 05/12/2015

Event Type  Injury  

Event Description

Oral surgeon called for ingredients in gluma desensitizer.(b)(6) returned call.Had examined male patient who had gluma placed 1 week ago, now has 1.5 sq cm lesion in buccal mucosa.The assistant at a general dental office had placed gluma, then applied gauze and did not rinse patient.The patient experienced burning pain immediately.A week later, the patient was referred to oral surgeon's office for consultation and possible biopsy.Surgeon then called hkna for ingredient list, and prescribed periogard (antimicrobial rinse) for the patient to help prevent secondary infection during the healing phase.This is a serious injury (as defined in 21 cfr section 803.3) as the patient reported having an adverse reaction.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# e2012008, heraeus kulzer llc (the importer) is submitting the report on behalf of heraeus kulzer (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.Evaluation summary: directions for use indicate rubber dam use is required.The office used no isolation and did not rinse patient, instead packed gauze over the affected area.Device not available for evaluation.

• Brand Name: GLUMA DESENSITIZER 1 X 5 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: 4799374
• MDR Text Key: 5880943
• Report Number: 9610902-2015-00011
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/19/2015

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: Dental Assistant
• Device Catalogue Number: 65872354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/19/2015
• Initial Date Manufacturer Received: 05/19/2015
• Initial Date FDA Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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