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 Problems Ulceration (2116); Complaint, Ill-Defined (2331)

Event Date 05/04/2015

Event Type  Injury  

Event Description

Call from patient, (b)(6).Pt stated she had gluma desensitizer treatment today and now has a spot on her lip that feels very rough.Patient stated the dental staff did not use rubber dam, only cotton roll isolation.She also said she tasted some of the product and was concerned about that.Pt gave contact info for her dds.Called and spoke with (b)(6).She confirmed that she had treated a patient and gotten some on the lip.Without disclosing name, she knew who had called me and the office had been in contact with the patient.I reiterated with (b)(6) that dfu state to use rubber dam.(b)(6) stated that because the patient's teeth were already sensitive and they would have needed to anesthetize the patient in order to use a rubber dam.(b)(6) said she would follow up with patient again.Left my contact info in case (b)(4) should have any additional information.(b)(6) called back (b)(6) 2015, stating her tongue was now red and she was concerned about that, as well.Recommended patient contact her dds as soon as they opened today.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

(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.Method/results/conclusion: directions for use indicate rubber dam use is required.The office used only cotton rolls for isolation, which is inadequate.Device was disposed of by office.

• 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 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: 4775401
• MDR Text Key: 15347074
• Report Number: 9610902-2015-00010
• 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: Patient
• Type of Report: Initial
• Report Date: 05/04/2015

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?: No
• Distributor Facility Aware Date: 05/04/2015
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 05/15/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR