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

Catalog Number 65872354

Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Issue (2379); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burning Sensation (2146)

Event Date 02/01/2015

Event Type  Injury  

Event Description

This occurred in (b)(6).Transcribed by (b)(6).Patient called hot line on (b)(6).Dentist sold gluma desensitizer to the patient.She was asked to use the product at home twice a week for 3 month.After the first use, she complained about a minor chemical burn on the tongue and called the manufacturer.On monday, (b)(6), the sibe mr.Dr.(b)(6) spoke to the patient: he asked her, not use the product for any longer on her own.The product has only to be used by the dentist with the safety precautions.The injury was very small and almost healed until monday, (b)(6).No permanent damage of body function.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

(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.Directions for use indicate rubber dam use is required, and the product in question must not be used if the necessary precautions cannot be taken or the specified application technique cannot be used.Further, gluma desensitizer should only be used by a dentist.In this incidence, the dentist gave the product to a patient to treat herself.This procedure was never proposed nor recommend in the directions for use.The actual device in question has not been returned by the patient.Device not returned by consumer.

• 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: 4546694
• MDR Text Key: 5524121
• Report Number: 9610902-2015-00004
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K962812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2015

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: Lay User/Patient
• Device Catalogue Number: 65872354
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/12/2015
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 02/25/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other