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

Catalog Number 65872354

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

Patient Problems Tingling (2171); Complaint, Ill-Defined (2331); Sensitivity of Teeth (2427)

Event Date 10/01/2014

Event Type  Injury  

Event Description

Letter received from patient, (b)(6) alleging multiple problems after application of gluma.Letter described many symptoms and ailments, including hot/cold sensitivity, tingling, itching, loss of appetite and weight loss, darkened and dry skin.Also included with the letter was a 1996 msds for gluma desensitizer, given to patient by her dds.After extraction of the tooth that was sensitive, her symptoms reportedly improved but did not dissipate entirely.This incident is reportable according to 21 cfr 803.The fda defines this as a serious injury (21 cfr sec.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.The incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.

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 patient reported having an adverse reaction.Because the malfunction allegation could not be confirmed, the cause of the adverse reaction could not be determined.(b)(4).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.The product was not returned nor evaluated.The lot number(s) were not provided.

• Brand Name: GLUMA DESENSITIZER
• 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 GMBH; philipp-reis-strasse 8/13; wehrheim, D-61 273; GM D-61273
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 4929580
• MDR Text Key: 6436886
• Report Number: 9610902-2015-00013
• 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: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/08/2015

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
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/29/2015
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 07/21/2015
• 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; Required Intervention
• Patient Age: 78 YR