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

Catalog Number 66001854

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

Patient Problems Swelling (2091); Burning Sensation (2146); Tingling (2171); Caustic/Chemical Burns (2549)

Event Date 09/24/2015

Event Type  Injury  

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 code: directions for use indicate rubber dam use is required.The office did not maintain isolation, which is inadequate.By immediately rinsing patient the dentist likely prevented further injury.Actual device has not been returned.Device not returned.

Event Description

Dds left a voice message for us regarding gluma desensitizer (gd) and a patient that had experienced anaphylactic reaction on thursday morning, (b)(6) 2015.The patient is an approximately (b)(6) year old female in for a cleaning appointment.She told the hygienist that her teeth are sensitive and the doctor applied gd, using a bend-a-brush, to the lingual and facial surfaces of teeth 7-10.I asked if a rubber dam was used and she said no.I asked what happened next and was told the patient said her gums were burning, then her upper lip began to swell, then her throat started to tingle.The doctor gave her a couple of benadryl tablets and one of her assistants drove the patient to a near-by minor care center.Once at the center, the patient said her throat began to close and it became hard to breathe.The clinic administered an epinephrine shot and gave her a steroid.I am not clear on the method of administration of the steroid.The doctor called the patient thursday evening and again on friday morning.The patient said she was feeling better but was exhausted from the experience.The doctor has not had contact with the patient since.I asked the doctor if the gd was rinsed and she indicated they rinsed for several minutes.

• Brand Name: GLUMA DESENSITIZER
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer (Section G): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 5150065
• MDR Text Key: 28243334
• Report Number: 9610902-2015-00015
• 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
• Report Date: 09/30/2015

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 Expiration Date: 03/31/2018
• Device Catalogue Number: 66001854
• Device Lot Number: 010219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/30/2015
• Device Age: 6 MO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 35 YR