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); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 11/11/2014

Event Type  Injury  

Event Description

Dental office staff member called.Female patient treated yesterday for crown delivery called today with sensitive gingiva and sore throat.Staff asked for medical advice, but was told we do not give medical advice.I asked about details of what had happened, staff said no isolation was used, the product was applied with "sponge on a stick", then sprayed with air syringe.Ceramir was then used to cement the crown.I arranged for pick up and replacement of product, and referred her to the dfu where rubber dam isolation is recommended.I also provided her with a list of ingredients for the patient to share with her physician.This incident is reportable according to 21cfr 803.The fda defines this as a serious injury (21 cfr sec 803.3) as the patient reported having an adverse reaction.The 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).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 code directions for use indicate rubber dam use is required.The office used no isolation, which is inadequate.The actual device has not yet been returned by the dental office.

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.The office used no isolation, which is inadequate.The actual device has not yet been returned by the dental office.3/11/2015 follow up and clarification: the product in question is never to come into contact with soft tissue, per dfu.Soft tissue injury is a foreseeable and preventable outcome of not maintaining product isolation to dentin surface of the teeth.3/03/2015 email from (b)(6): (while) preparing the post market surveillance report for the fourth quarter 2014 i found this report.Report was maude adverse event report, generated by patient: event date (b)(6) 2014, event type injury, event description, my dentist used gluma on my gum area during a procedure and it leaked to the soft palate and tonsil area of my mouth.The area started to burn while at the office and dentist was notified.The next day the area was swollen and blistered.Dentist was called and i was examined and told i was allergic to it.Diagnosis or reason for use: dental restorative procedure.New search submit an adverse event report24 brand name gluma, type of device gluma, device event key (b)(4), mdr report key (b)(4), event key (b)(4), report number mw5039155, device sequence number 1, product code kle25.Product was not returned.

Event Description

Dental office staff member called.Female patient treated yesterday for crown delivery called today with sensitive gingiva and sore throat.Staff asked for medical advice, but was told we do not give medical advice.I asked about details of what had happened, staff said no isolation was used, the product was applied with "sponge on a stick", then sprayed with air syringe.Ceramir was then used to cement the crown.I arranged for pick up and replacement of product, and referred her to the dfu where rubber dam isolation is recommended.I also provided her with a list of ingredients for the patient to share with her physician.This incident is reportable according to 21cfr 803.The fda defines this as a serious injury (21 cfr sec 803.3) as the patient reported having an adverse reaction.The incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.

• 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: 4268768
• MDR Text Key: 17995401
• Report Number: 9610902-2014-00052
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2014

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 Expiration Date: 08/01/2017
• Device Catalogue Number: 65872354
• Device Lot Number: 010215
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/12/2014
• Device Age: 3 MO
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 11/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2014
• 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